CS100 Accessory Kit - English International, 220V 0020-00-0463-02

GUDID 10607567107288

CS100 Accessory Kit - English International, 220V

Datascope Corp.

Intra-aortic balloon pump
Primary Device ID10607567107288
NIH Device Record Keyf36f0fbe-41a5-4f11-bd87-311dbc7250a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameCS100 Accessory Kit - English International, 220V
Version Model Number0020-00-0463-02
Catalog Number0020-00-0463-02
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 Kittrue
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

Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110607567107288 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSPSystem, Balloon, Intra-Aortic And Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-06
Device Publish Date2016-09-19

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.