Sensation 7Fr. 40cc IAB (China) 0684-00-0470-01C

GUDID 10607567109374

Sensation 7Fr. 40cc IAB (China)

DATASCOPE CORP.

Intra-aortic balloon catheter
Primary Device ID10607567109374
NIH Device Record Keyb7a7aacd-2aee-4ca7-a286-1be380a73b0f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSensation 7Fr. 40cc IAB (China)
Version Model Number0684-00-0470-01C
Catalog Number0684-00-0470-01C
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

Device Dimensions

Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French

Device Identifiers

Device Issuing AgencyDevice ID
GS110607567109374 [Primary]

FDA Product Code

DSPSystem, Balloon, Intra-Aortic And Control

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10607567109374]

Ethylene Oxide


[10607567109374]

Ethylene Oxide


[10607567109374]

Ethylene Oxide


[10607567109374]

Ethylene Oxide


[10607567109374]

Ethylene Oxide


[10607567109374]

Ethylene Oxide


[10607567109374]

Ethylene Oxide


[10607567109374]

Ethylene Oxide


[10607567109374]

Ethylene Oxide


[10607567109374]

Ethylene Oxide


[10607567109374]

Ethylene Oxide


[10607567109374]

Ethylene Oxide


[10607567109374]

Ethylene Oxide


[10607567109374]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-12-06
Device Publish Date2016-09-15

Devices Manufactured by DATASCOPE CORP.

10607567104713 - CABLE,EXTERNAL SIGNAL,IABP2024-08-05
10607567112817 - CARDIOSAVE LI-ION SINGLE BTTY TRANSPORT2024-08-05
10607567113760 - CABLE ASSEMBLY, BLOOD PRESSURE TRANSDUCE2024-08-05 CABLE ASSEMBLY, BLOOD PRESSURE TRANSDUCE
10607567113777 - CABLE,LOW LEVEL OUTPUT,PHILIPS2024-08-05 CABLE,LOW LEVEL OUTPUT,PHILIPS
10607567113784 - CABLE,LOW LEVEL OUTPUT,GE2024-08-05
10607567113807 - CABLE,INTERFACE,1/4-1/4",30'2024-08-05
10607567113814 - CABLE, INTERFACE .25" PLUG TO .25" PLUG 302024-08-05 CABLE, INTERFACE 1/4" PLUG TO 1/4" PLUG 30
10607567113821 - CABLE, INTERFACE 1/4” PLUG TO 1/8” PLUG,2024-08-05

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