GUDID 00613994897923

KIT 5866-37M ADAPTER FORMSCAPE NO CE

MEDTRONIC, INC.

Pacing/defibrillation lead electrical extension adaptor
Primary Device ID00613994897923
NIH Device Record Key2935fc4e-caf7-4535-92da-dea15c00fda7
Commercial Distribution Discontinuation2018-10-10
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number5866-37M
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 Usetrue
Lot Batchfalse
Serial Numbertrue
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994897923 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTDpacemaker lead Adaptor

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-12
Device Publish Date2015-06-10

Devices Manufactured by MEDTRONIC, INC.

20763000974996 - NA2024-09-17 CUSTOM PACK BB11J93R1 5PK OMCE
20763000975016 - NA2024-09-17 CUSTOM PACK BB10M39R3 10PK VAMP/ACC
00763000975197 - NA2024-09-17 CUSTOM PACK BB8G55R17 A PACK
00763000974190 - NA2024-09-16 CUSTOM PACK HY9L80R7 SADT FUS
00763000974251 - NA2024-09-16 CUSTOM PACK HY4D49R18 LEFT HBY
00763000975135 - NA2024-09-16 CUSTOM PACK BB12G92R4 L PEDI/S ADUL
00763000974572 - NA2024-09-10 CUSTOM PACK BB3X42R20 UNV
20763000181080 - NA2024-09-09 CABLE 5833SL SURGICAL5PK DISP

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.