Adult ECC 701050253

GUDID 00607567205499

BEQ-HMOD 70000 Better Bladder 3/8 CDI Sat Cell 3/8" Gas Filter

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set
Primary Device ID00607567205499
NIH Device Record Key5b184aac-a175-4c2c-83c1-e4e07fc3918e
Commercial Distribution Discontinuation2018-07-20
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAdult ECC
Version Model NumberBEQ-TOP 24500
Catalog Number701050253
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 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
GS100607567205499 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWETubing, Pump, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00607567205499]

Ethylene Oxide


[00607567205499]

Ethylene Oxide


[00607567205499]

Ethylene Oxide


[00607567205499]

Ethylene Oxide


[00607567205499]

Ethylene Oxide


[00607567205499]

Ethylene Oxide


[00607567205499]

Ethylene Oxide


[00607567205499]

Ethylene Oxide


[00607567205499]

Ethylene Oxide


[00607567205499]

Ethylene Oxide


[00607567205499]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-02
Device Publish Date2016-01-05

On-Brand Devices [Adult ECC ]

00607567205499BEQ-HMOD 70000 Better Bladder 3/8 CDI Sat Cell 3/8" Gas Filter
00607567203655BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 3/8, SAT/CRIT
00607567203037BEQ-HMOD 70000 Softshell venous reservoir 800 ml CDI Sat cell 3/8" Blood Microfilter system Preb
00607567212404BEQ-HNOD 70000-USA Adult QuadroxiD, Softshell Venous Reserv. 800ml, Better Bladder 3/8, CDI Sat
00607567213111BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, CDI Sai Cell 3/8" System 100

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