GUDID 00643169431850

CABLE 5437 ROHS GLB 10L

MEDTRONIC, INC.

Electrical-only medical device connection cable, reusable
Primary Device ID00643169431850
NIH Device Record Key0a686d62-71fc-4c1b-8e79-bb0d7743fca7
Commercial Distribution StatusIn Commercial Distribution
Version Model Number5437
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169431850 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXYimplantable pacemaker Pulse-generator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-07-01

Devices Manufactured by MEDTRONIC, INC.

00199150033966 - NA2025-08-04 CUSTOM PACK BB10N41R3 SUPPORT SM
00199150034017 - NA2025-08-04 CUSTOM PACK BB9P05R5 316/14
20199150034172 - NA2025-08-04 CUSTOM PACK BB12Q65R 10PK UC BAL TUB14-8
00199150034239 - NA2025-08-04 CUSTOM PACK 12Q76R VAVD PK
00199150034345 - NA2025-08-04 CUSTOM PACK BB11R40R8 TRANS PORT
00199150034352 - NA2025-08-04 CUSTOM PACK BB9P03R5 14/38 AV
00199150034369 - NA2025-08-04 CUSTOM PACK BB9Q43R4 38/12 AV
20199150034394 - NA2025-08-04 CUSTOM PACK BB12N77R1 4PK 3/8 STRAIGHT

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.