PGRM 24967 USA CAN MKT HEAD Medical Device Identification

GUDID 00763000688479

PGRM 24967 USA CAN MKT HEAD

MEDTRONIC, INC.

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Primary Device ID	00763000688479
NIH Device Record Key	f4b81aa8-7f34-47ab-b26b-686eb7a47bb3
Commercial Distribution Status	In Commercial Distribution
Version Model Number	24967
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

Operating and Storage Conditions

Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -30 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -30 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -30 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -30 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -30 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -30 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -30 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -30 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -30 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -30 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -30 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -30 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -30 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -30 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -30 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -30 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -30 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -30 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000688479 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P890003

FDA Product Code

DSI	DETECTOR AND ALARM, ARRHYTHMIA

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	2022-11-07
Device Publish Date	2022-10-28

Devices Manufactured by MEDTRONIC, INC.

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00763000953614 - NA	2024-05-31 CUSTOM PACK HY0A20R46 CHRST NN
00763000953621 - NA	2024-05-31 CUSTOM PACK BB11Q49R11 3/8 EC
00763000953638 - NA	2024-05-31 CUSTOM PACK BB12A45R1 SMALL LOOP
00763000953645 - NA	2024-05-31 CUSTOM PACK BB12A44R2 LRG AV LOOP
20763000953663 - NA	2024-05-31 CUSTOM PACK BB12G60R 2PK 2PK CHRST TBL
00763000953676 - NA	2024-05-31 CUSTOM PACK BB7B00R26 UW CMAG PK