CS100 Accessory Kit - English International, 220V 0020-00-0463-02

GUDID 10607567107288

CS100 Accessory Kit - English International, 220V

Datascope Corp.

Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump Intra-aortic balloon pump
Primary Device ID10607567107288
NIH Device Record Keyf36f0fbe-41a5-4f11-bd87-311dbc7250a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameCS100 Accessory Kit - English International, 220V
Version Model Number0020-00-0463-02
Catalog Number0020-00-0463-02
Company DUNS040874329
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
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
Phone888-627-8383
Emailcustomer.support@maquet.com
Phone888-627-8383
Emailcustomer.support@maquet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110607567107288 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSPSystem, Balloon, Intra-Aortic And Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-06
Device Publish Date2016-09-19

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