CABLE,EXTERNAL SIGNAL,IABP 0012-00-0323

GUDID 10607567104713

Datascope Corp.

Electrical-only medical device connection cable, reusable
Primary Device ID10607567104713
NIH Device Record Key4a2cf6cc-131c-462c-8295-dbcd3e830922
Commercial Distribution StatusIn Commercial Distribution
Brand NameCABLE,EXTERNAL SIGNAL,IABP
Version Model Number0012-00-0323
Catalog Number0012-00-0323
Company DUNS040874329
Company NameDatascope Corp.
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS110607567104713 [Primary]

FDA Product Code

DSPSystem, Balloon, Intra-Aortic And Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-05
Device Publish Date2024-07-26

Devices Manufactured by Datascope Corp.

10607567113432 - CARDIOSAVE HYBRID, 3.1 EDITION2024-09-17 CARDIOSAVE HYBRID, 3.1 EDITION
10607567113449 - CARDIOSAVE RESCUE, 3.1 EDITION2024-09-17 CARDIOSAVE RESCUE, 3.1 EDITION
10607567114187 - CARDIOSAVE HYBRID - TYPE "N" PLUG2024-09-17 CARDIOSAVE HYBRID - TYPE "N" PLUG
10607567107585 - YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT2024-08-20 YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT
10607567107592 - YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA)2024-08-20 YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA)
10607567107608 - YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT2024-08-20 YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT
10607567107639 - YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA)2024-08-20 YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA)
10607567111537 - Catheter Extender for Yamato Plus IABs - 10 Pack2024-08-20 Catheter Extender for Yamato Plus IABs - 10 Pack

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