Linear 7.5Fr. 25cc IAB (INDIA) 0684-00-0478-07

GUDID 10607567109671

Linear 7.5Fr. 25cc IAB (INDIA)

DATASCOPE CORP.

Intra-aortic balloon catheter Intra-aortic balloon catheter Intra-aortic balloon catheter Intra-aortic balloon catheter Intra-aortic balloon catheter Intra-aortic balloon catheter Intra-aortic balloon catheter Intra-aortic balloon catheter Intra-aortic balloon catheter Intra-aortic balloon catheter Intra-aortic balloon catheter Intra-aortic balloon catheter Intra-aortic balloon catheter Intra-aortic balloon catheter
Primary Device ID10607567109671
NIH Device Record Keycff59d75-dfa3-4197-98f8-32026726925d
Commercial Distribution StatusIn Commercial Distribution
Brand NameLinear 7.5Fr. 25cc IAB (INDIA)
Version Model Number0684-00-0478-07
Catalog Number0684-00-0478-07
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 Gauge7.5 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
GS110607567109671 [Primary]

FDA Product Code

DSPSystem, Balloon, Intra-Aortic And Control

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10607567109671]

Ethylene Oxide


[10607567109671]

Ethylene Oxide


[10607567109671]

Ethylene Oxide


[10607567109671]

Ethylene Oxide


[10607567109671]

Ethylene Oxide


[10607567109671]

Ethylene Oxide


[10607567109671]

Ethylene Oxide


[10607567109671]

Ethylene Oxide


[10607567109671]

Ethylene Oxide


[10607567109671]

Ethylene Oxide


[10607567109671]

Ethylene Oxide


[10607567109671]

Ethylene Oxide


[10607567109671]

Ethylene Oxide


[10607567109671]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-12-06
Device Publish Date2016-09-16

Devices Manufactured by DATASCOPE CORP.

10607567114170 - Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB2024-02-28 Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB
10607567114194 - Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 34cc & 40cc I2024-02-28 Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 34cc & 40cc IABs
10607567114200 - Insertion Kit with 6” (15cm) Introducer for use with Sensation 7Fr. 34cc & 40cc 2024-02-28 Insertion Kit with 6” (15cm) Introducer for use with Sensation 7Fr. 34cc & 40cc IABs
10607567114217 - Insertion Kit with 6” (15cm) Introducer for use with MEGA 8Fr. 50cc IAB2024-02-28 Insertion Kit with 6” (15cm) Introducer for use with MEGA 8Fr. 50cc IAB
10607567114224 - Insertion Kit with 6” (15cm) Introducer for use with MEGA 7.5Fr. 30 & 40cc IABs2024-02-28 Insertion Kit with 6” (15cm) Introducer for use with MEGA 7.5Fr. 30 & 40cc IABs
10607567114231 - Insertion Kit with 7.5Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 72024-02-28 Insertion Kit with 7.5Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 7.5Fr 40cc IAB
10607567114248 - Insertion Kit with 8Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 8Fr2024-02-28 Insertion Kit with 8Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 8Fr 50cc IAB
10607567113128 - Sensation 7Fr 34cc IAB with Accessories (Turkey)2023-05-16 Sensation 7Fr 34cc IAB with Accessories (Turkey)

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