YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA) 0684-00-0561-02

GUDID 10607567107639

YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA)

DATASCOPE CORP.

Intra-aortic balloon catheter
Primary Device ID10607567107639
NIH Device Record Key5f85c632-fa1b-4dbc-b237-de7b26bcea20
Commercial Distribution StatusIn Commercial Distribution
Brand NameYAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA)
Version Model Number0684-00-0561-02
Catalog Number0684-00-0561-02
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
GS110607567107639 [Primary]

FDA Product Code

DSPSystem, Balloon, Intra-Aortic And Control

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10607567107639]

Ethylene Oxide


[10607567107639]

Ethylene Oxide


[10607567107639]

Ethylene Oxide


[10607567107639]

Ethylene Oxide


[10607567107639]

Ethylene Oxide


[10607567107639]

Ethylene Oxide


[10607567107639]

Ethylene Oxide


[10607567107639]

Ethylene Oxide


[10607567107639]

Ethylene Oxide


[10607567107639]

Ethylene Oxide


[10607567107639]

Ethylene Oxide


[10607567107639]

Ethylene Oxide


[10607567107639]

Ethylene Oxide


[10607567107639]

Ethylene Oxide


[10607567107639]

Ethylene Oxide


[10607567107639]

Ethylene Oxide


[10607567107639]

Ethylene Oxide


Device Entry Metadata

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

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10607567114187 - CARDIOSAVE HYBRID - TYPE "N" PLUG2024-09-17 CARDIOSAVE HYBRID - TYPE "N" PLUG
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10607567107639 - YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA)2024-08-20YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA)
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)
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