GUDID 00613994647870

HANDCRANK HC150A

MEDTRONIC, INC.

Centrifugal circulatory assist pump, manual
Primary Device ID00613994647870
NIH Device Record Key3216014e-50cd-485d-8277-37e0d9cf2d3f
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994647870 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-06-09

Devices Manufactured by MEDTRONIC, INC.

00763000180010 - Sprint Quattro Secure S™2024-11-12 LEAD 693552 SPRINT US RCMCRD
00763000180027 - Sprint Quattro Secure S™2024-11-12 LEAD 693575 SPRINT US RCMCRD
00763000180034 - Sprint Quattro Secure S™2024-11-12 LEAD 6935100 SPRINT US RCMCRD
00763000180041 - Sprint Quattro Secure S MRI™ SureScan™2024-11-12 LEAD 693558 SPRINT MRI US RCMCRD
00763000180058 - Sprint Quattro Secure S MRI™ SureScan™2024-11-12 LEAD 693565 SPRINT MRI US RCMCRD
00763000180119 - Sprint Quattro Secure S MRI™ SureScan™2024-11-12 LEAD 6935M55 MRI US DF4 RCMCRD
00763000180126 - Sprint Quattro Secure S MRI™ SureScan™2024-11-12 LEAD 6935M62 MRI US DF4 RCMCRD
00763000180133 - Sprint Quattro Secure S™2024-11-12 LEAD 6935M49 US DF4 RCMCRD

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