GUDID 00763000108274

HANDCRANK HC150A PLX

MEDTRONIC, INC.

Centrifugal circulatory assist pump, manual
Primary Device ID00763000108274
NIH Device Record Keycf3e4ad4-80b1-4b86-84a7-044f31a22044
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberHC150A
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 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

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000108274 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWAControl, pump speed, cardiopulmonary bypass

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-15
Device Publish Date2019-03-07

Devices Manufactured by MEDTRONIC, INC.

00763000897642 - Launcher™2024-05-15 CATHETER LA6ALR12A LA 6F 110CM ALR12
00763000897659 - Launcher™2024-05-15 CATHETER LA6AR10A LA 6F 110CM AR10
00763000897666 - Launcher™2024-05-15 CATHETER LA6AR20A LA 6F 110CM AR20
00763000897673 - Launcher™2024-05-15 CATHETER LA6AL30A LA 6F 110CM AL30
00763000897680 - Launcher™2024-05-15 CATHETER LA6AL40A LA 6F 110CM AL40
00763000897697 - Launcher™2024-05-15 CATHETER LA6HSIA LA 6F 110CM HSI
00763000897703 - Launcher™2024-05-15 CATHETER LA6HSIIA LA 6F 110CM HSII
00763000897710 - Launcher™2024-05-15 CATHETER LA6JCL40A LA 6F 110CM JCL40

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