CONSOLE 106A3 GEN V ROHS PLX Medical Device Identification

GUDID 00763000486778

CONSOLE 106A3 GEN V ROHS PLX

MEDTRONIC, INC.

Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system Cardiac cryosurgical system

Primary Device ID	00763000486778
NIH Device Record Key	a395fd01-96ce-4293-bf53-ab166312b99d
Commercial Distribution Status	In Commercial Distribution
Version Model Number	106A3
Company DUNS	006261481
Company Name	MEDTRONIC, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *This way up
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Fragile: handle with care
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000486778 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P020045

FDA Product Code

LPB	Cardiac ablation percutaneous catheter

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-07-10
Device Publish Date	2023-07-01

Devices Manufactured by MEDTRONIC, INC.

00763000902537 - Launcher™	2024-06-04 CATHETER LA83DRCD LA 8F 90CM 3DRC
00763000902544 - Launcher™	2024-06-04 CATHETER LA83DRCSH LA 8F 100CM 3DRC
00763000902551 - Launcher™	2024-06-04 CATHETER LA83DRCSHD LA 8F 90CM 3DRC
00763000902568 - Launcher™	2024-06-04 CATHETER LA83DRIGHT LA 8F 100CM 3DRGT
00763000902575 - Launcher™	2024-06-04 CATHETER LA83DRIGHTD LA 8F 90CM 3DRGT
00763000902582 - Launcher™	2024-06-04 CATHETER LA8AL10 LA 8F 100CM AL10
00763000902599 - Launcher™	2024-06-04 CATHETER LA8AL10D LA 8F 90CM AL10
00763000902605 - Launcher™	2024-06-04 CATHETER LA8AL10F LA 8F 80CM AL10