Quadrox iD Plus Pack Bioline 709000477

GUDID 00607567211187

BEQ-HMOD 70000-USA Adult Quadrox iD Softshell Venous Reser. 1900ml w. connector 700000292 Gas Filter

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set
Primary Device ID00607567211187
NIH Device Record Key7cd520ee-74c3-4ebb-9e9d-693eb7270209
Commercial Distribution Discontinuation2018-02-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameQuadrox iD Plus Pack Bioline
Version Model NumberBEQ-TOP 8081
Catalog Number709000477
Company DUNS001660786
Company NameDATASCOPE CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does n
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18886278383
Emailcpsurgery@maquet.com
Phone18886278383
Emailcpsurgery@maquet.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100607567211187 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWETubing, Pump, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00607567211187]

Ethylene Oxide


[00607567211187]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-02-01

On-Brand Devices [Quadrox iD Plus Pack Bioline]

00607567211872BEQ-HMOD 70000-USA Adult Quadrox iD Softshell Venous Reser. 1900ml w. connector 700000292 Gas Fi
00607567211187BEQ-HMOD 70000-USA Adult Quadrox iD Softshell Venous Reser. 1900ml w. connector 700000292 Gas Fi

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