3/8x3/8 Pack with Quadrox iD 701065913R02

GUDID 00607567210066

BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set
Primary Device ID00607567210066
NIH Device Record Key5c8cbb72-4457-4c99-8e47-0eb4c4bd672a
Commercial Distribution Discontinuation2018-07-21
Commercial Distribution StatusNot in Commercial Distribution
Brand Name3/8x3/8 Pack with Quadrox iD
Version Model NumberBEQ-TOP 8503
Catalog Number701065913R02
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18886278383
Emailcpsurgery@maquet.com
Phone18886278383
Emailcpsurgery@maquet.com
Phone18886278383
Emailcpsurgery@maquet.com
Phone18886278383
Emailcpsurgery@maquet.com
Phone18886278383
Emailcpsurgery@maquet.com
Phone18886278383
Emailcpsurgery@maquet.com
Phone18886278383
Emailcpsurgery@maquet.com
Phone18886278383
Emailcpsurgery@maquet.com
Phone18886278383
Emailcpsurgery@maquet.com
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
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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
GS100607567210066 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWETubing, Pump, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00607567210066]

Ethylene Oxide


[00607567210066]

Ethylene Oxide


[00607567210066]

Ethylene Oxide


[00607567210066]

Ethylene Oxide


[00607567210066]

Ethylene Oxide


[00607567210066]

Ethylene Oxide


[00607567210066]

Ethylene Oxide


[00607567210066]

Ethylene Oxide


[00607567210066]

Ethylene Oxide


[00607567210066]

Ethylene Oxide


[00607567210066]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-02
Device Publish Date2016-08-16

On-Brand Devices [3/8x3/8 Pack with Quadrox iD ]

00607567210363BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 3/8, Blood Mi
00607567210066BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Blood Microfilter System SQ

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