CUSTOM PACK 10J59R 20PK QUICK DISCONNECT Medical Device Identification

GUDID 20763000099965

CUSTOM PACK 10J59R 20PK QUICK DISCONNECT

MEDTRONIC, INC.

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Primary Device ID	20763000099965
NIH Device Record Key	65b50e3e-d2a2-4bd9-9584-a1b3773a9018
Commercial Distribution Discontinuation	2018-10-24
Commercial Distribution Status	Not in Commercial Distribution
Version Model Number	10J59R
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	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
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

Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000099954 [Primary]
GS1	20763000099965 [Package] Contains: 00763000099954 Package: PK [20 Units] Discontinued: 2018-10-24 Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K171308

FDA Product Code

DWF	Catheter, cannula and tubing, vascular, cardiopulmonary bypass

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2018-12-11
Device Publish Date	2018-02-05

Devices Manufactured by MEDTRONIC, INC.

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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