GUDID 20613994923275

CRTG 304-20POR PORC HDR 5L INT 9BX

MEDTRONIC, INC.

Heparin anti-Xa IVD, kit, chromogenic
Primary Device ID20613994923275
NIH Device Record Key01f26278-1223-45b0-aede-d71aa1b5b082
Commercial Distribution StatusIn Commercial Distribution
Version Model Number304-20POR
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count9
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 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

Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated 2°C-10°C

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994923271 [Unit of Use]
GS120613994923275 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JBPACTIVATED WHOLE BLOOD CLOTTING TIME

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 Date2016-07-29

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.