CARDIOSAVE Accessory Kit, AAMI 0020-00-0480-01

GUDID 10607567108544

CARDIOSAVE Accessory Kit, AAMI

Datascope Corp.

Intra-aortic balloon pump
Primary Device ID10607567108544
NIH Device Record Keya94aca1b-751d-4f49-b06c-fb16b909da31
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARDIOSAVE Accessory Kit, AAMI
Version Model Number0020-00-0480-01
Catalog Number0020-00-0480-01
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 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

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
GS110607567108544 [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 Date2016-09-20

Devices Manufactured by Datascope Corp.

10607567107301 - MEGA 8Fr. 50cc IAB2024-12-09 MEGA 8Fr. 50cc IAB
10607567107318 - MEGA 8Fr. 50cc IAB (with APA)2024-12-09 MEGA 8Fr. 50cc IAB (with APA)
10607567107479 - Arrow Pump Adapter - 5 Pack - for use with the Mega 8 Fr. 50cc IAB only2024-12-09 Arrow Pump Adapter - 5 Pack - for use with the Mega 8 Fr. 50cc IAB only
10607567107516 - Catheter Extenders for 50cc IAB’s 2024-12-09 Catheter Extenders for 50cc IAB’s
10607567108001 - MEGA 8Fr. 50cc IAB (with Statlock)2024-12-09 MEGA 8Fr. 50cc IAB (with Statlock)
10607567108018 - MEGA 8Fr. 50cc IAB (with Statlock & APA)2024-12-09 MEGA 8Fr. 50cc IAB (with Statlock & APA)
10607567108063 - SENSATION PLUS 7.5Fr. 40cc IAB & Accessories2024-12-09 SENSATION PLUS 7.5Fr. 40cc IAB & Accessories
10607567108605 - SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet)2024-12-09 SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet)

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