GUDID 00613994416551

CONTROL 55096 PROFICIENCY KIT

MEDTRONIC, INC.

Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control
Primary Device ID00613994416551
NIH Device Record Keyf768765e-8b2a-46d4-87ce-1dadcfdd08d6
Commercial Distribution StatusIn Commercial Distribution
Version Model Number55096
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 Perscriptionfalse
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 TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994416551 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKNTimer, clot, automated

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 Date2016-04-30

Devices Manufactured by MEDTRONIC, INC.

00763000959067 - NA2024-07-02 CUSTOM PACK BB5348R24 PHOEBE P
20763000959818 - NA2024-07-02 CUSTOM PACK BB12G18R1 10PK EXTRA CPG LN
00763000957544 - NA2024-06-28 CUSTOM PACK BB7J30R4 LIV SHUNT
00763000957551 - NA2024-06-28 CUSTOM PACK BBB7S09R13 SUPPRT SM
20763000957760 - NA2024-06-28 CUSTOM PACK BB12G13R 5PK FL MEM MANIFOL
00763000957780 - NA2024-06-28 CUSTOM PACK 11H88R7 ACCESSORY PACK
00763000958015 - NA2024-06-28 CUSTOM PACK HY11R06R2 SUPP 1/4 PK
20763000958033 - NA2024-06-28 CUSTOM PACK BB9B82R2 5PK JUMP PACK

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