TRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIES 0684-00-0607

GUDID 10607567111711

TRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIES

DATASCOPE CORP.

Intra-aortic balloon catheter
Primary Device ID10607567111711
NIH Device Record Key75d27e13-d691-4da1-916d-f8c8d519c3eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIES
Version Model Number0684-00-0607
Catalog Number0684-00-0607
Company DUNS001660786
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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

Device Dimensions

Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French
Catheter Gauge7.5 French

Device Identifiers

Device Issuing AgencyDevice ID
GS110607567111711 [Primary]

FDA Product Code

DSPSystem, Balloon, Intra-Aortic And Control

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10607567111711]

Ethylene Oxide


[10607567111711]

Ethylene Oxide


[10607567111711]

Ethylene Oxide


[10607567111711]

Ethylene Oxide


[10607567111711]

Ethylene Oxide


[10607567111711]

Ethylene Oxide


[10607567111711]

Ethylene Oxide


[10607567111711]

Ethylene Oxide


[10607567111711]

Ethylene Oxide


[10607567111711]

Ethylene Oxide


[10607567111711]

Ethylene Oxide


[10607567111711]

Ethylene Oxide


[10607567111711]

Ethylene Oxide


[10607567111711]

Ethylene Oxide


[10607567111711]

Ethylene Oxide


[10607567111711]

Ethylene Oxide


[10607567111711]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-20
Device Publish Date2024-08-12

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.