Linear 7.5Fr 40cc IAB with Accessories (APA) (Turkey) 0684-00-0480-10

GUDID 10607567113159

Linear 7.5Fr 40cc IAB with Accessories (APA) (Turkey)

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 Intra-aortic balloon catheter Intra-aortic balloon catheter Intra-aortic balloon catheter
Primary Device ID10607567113159
NIH Device Record Key8edb65e8-ea44-48eb-bd3e-ecd1e943fa40
Commercial Distribution StatusIn Commercial Distribution
Brand NameLinear 7.5Fr 40cc IAB with Accessories (APA) (Turkey)
Version Model Number0684-00-0480-10
Catalog Number0684-00-0480-10
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
GS110607567113159 [Primary]

FDA Product Code

DSPSystem, Balloon, Intra-Aortic And Control

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10607567113159]

Ethylene Oxide

[10607567113159]

Ethylene Oxide

[10607567113159]

Ethylene Oxide

[10607567113159]

Ethylene Oxide

[10607567113159]

Ethylene Oxide

[10607567113159]

Ethylene Oxide

[10607567113159]

Ethylene Oxide

[10607567113159]

Ethylene Oxide

[10607567113159]

Ethylene Oxide

[10607567113159]

Ethylene Oxide

[10607567113159]

Ethylene Oxide

[10607567113159]

Ethylene Oxide

[10607567113159]

Ethylene Oxide

[10607567113159]

Ethylene Oxide

[10607567113159]

Ethylene Oxide

[10607567113159]

Ethylene Oxide

[10607567113159]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-16
Device Publish Date2023-05-08

Devices Manufactured by DATASCOPE CORP.

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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)
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