ECC Quadrox ID Pack RF 701047962

GUDID 00607567203273

BEQ-HMOD 70000- USA Adult Quadrox ID Blood Transfer Bag 600 ml BEQ-RF32 RotaFLow Gas Filter Temperature Probe

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set
Primary Device ID00607567203273
NIH Device Record Keybe26d392-5dad-4210-9158-5baa6ee6f144
Commercial Distribution StatusIn Commercial Distribution
Brand NameECC Quadrox ID Pack RF
Version Model NumberBEQ-TOP 8013
Catalog Number701047962
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 Latextrue
Labeled No Natural Rubber Latexfalse
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 HumidityBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100607567203273 [Primary]

FDA Product Code

DWETubing, Pump, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00607567203273]

Ethylene Oxide


[00607567203273]

Ethylene Oxide


[00607567203273]

Ethylene Oxide


[00607567203273]

Ethylene Oxide


[00607567203273]

Ethylene Oxide


[00607567203273]

Ethylene Oxide


[00607567203273]

Ethylene Oxide


[00607567203273]

Ethylene Oxide


[00607567203273]

Ethylene Oxide


[00607567203273]

Ethylene Oxide


[00607567203273]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-10-31

On-Brand Devices [ECC Quadrox ID Pack RF]

00607567212022BEQ-HMOD 70000-USA Adult Quadrox iD, Blood Transfer Bag 600ml, BEQ- RF32 Rotaflow, Gas Filter, t
00607567203273BEQ-HMOD 70000- USA Adult Quadrox ID Blood Transfer Bag 600 ml BEQ-RF32 RotaFLow Gas Filter Temp

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