GUDID 00763000233419

CUSTOM PACK HY9L88R13 FUSION ST

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set
Primary Device ID00763000233419
NIH Device Record Key73f28e87-5471-4dc3-8354-dbb07bb6a251
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberHY9L88R13
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000233419 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-29
Device Publish Date2018-12-29

Devices Manufactured by MEDTRONIC, INC.

00763000449711 - INTERSTIM® II2025-12-16 INS 3058 IS II EMAN US
00199150062980 - NA2025-12-15 CUSTOM PACK BB9H69R15 HLO H/LW/VAV
00199150063390 - NA2025-12-15 CUSTOM PACK 10D80R1 ACC TEMP PROBE
00199150063550 - NA2025-12-15 CUSTOM PACK BB7W91R29 HLO OH PACK2
00763000929374 - NA2025-12-15 WIRELESS RECHARGER P720R1 ALTAVIVA
20199150061970 - NA2025-12-08 CUSTOM PACK BB12R02R3 5PK ACC STRNG SUC
00199150062027 - NA2025-12-08 CUSTOM PACK BB12R85R AVL 3/8 ECCPK
20199150062229 - NA2025-12-08 CUSTOM PACK BB1Q47R3 5PK ACC TABLE

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