GUDID 00681490472685

ONE SOURCE PACK ATLS15 AUTOLOG ATL1005

MEDTRONIC, INC.

Blood-processing autotransfusion system set
Primary Device ID00681490472685
NIH Device Record Key2346ca00-a67c-4b9c-b028-4471ebae167a
Commercial Distribution Discontinuation2018-10-05
Commercial Distribution StatusNot in Commercial Distribution
Version Model NumberATLS15
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 Kittrue
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 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
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100681490472685 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CACAPPARATUS, AUTOTRANSFUSION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-01-04
Device Publish Date2015-06-17

Devices Manufactured by MEDTRONIC, INC.

20763000980096 - NA2025-08-25 IMPEDANCE PATCH AFR-00015
20763000980119 - NA2025-08-25 MAGNETIC PATCH AFR-00021
00199150039371 - NA2025-08-22 CUSTOM PACK BB11U72R1 P/T
00199150040872 - NA2025-08-22 CUSTOM PACK BB4K95R22 HLO PERFNPLEG
00199150041145 - NA2025-08-22 CUSTOM PACK BB12Q87R1 HLN VAMC NASH
00199150041978 - NA2025-08-22 CUSTOM PACK BB10F40R2 ACCESORY
00199150041299 - NA2025-08-19 CUSTOM PACK BB8E60R12 EVL PED E
20199150041118 - NA2025-08-18 CUSTOM PACK BB12E30R1 10PK ACC BRIDGE

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