MEGA 8Fr. 50cc IAB 0684-00-0498-01

GUDID 10607567107301

MEGA 8Fr. 50cc IAB

DATASCOPE CORP.

Intra-aortic balloon catheter
Primary Device ID10607567107301
NIH Device Record Key7f9e07c6-a71b-4bce-9d0d-5b72d7b982a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEGA 8Fr. 50cc IAB
Version Model Number0684-00-0498-01
Catalog Number0684-00-0498-01
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

Device Dimensions

Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French

Device Identifiers

Device Issuing AgencyDevice ID
GS110607567107301 [Primary]

FDA Product Code

DSPSystem, Balloon, Intra-Aortic And Control

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10607567107301]

Ethylene Oxide

[10607567107301]

Ethylene Oxide

[10607567107301]

Ethylene Oxide

[10607567107301]

Ethylene Oxide

[10607567107301]

Ethylene Oxide

[10607567107301]

Ethylene Oxide

[10607567107301]

Ethylene Oxide

[10607567107301]

Ethylene Oxide

[10607567107301]

Ethylene Oxide

[10607567107301]

Ethylene Oxide

[10607567107301]

Ethylene Oxide

[10607567107301]

Ethylene Oxide

[10607567107301]

Ethylene Oxide

[10607567107301]

Ethylene Oxide

[10607567107301]

Ethylene Oxide

[10607567107301]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-12-09
Device Publish Date2016-09-15

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