Small Patient Circuit 701052287

GUDID 00607567203006

BEQ-HMOD 30000 Soft Shell Venous Reservoir 800 Better Bladder 1/4 CDI Sat Cell Blood Microfilter system Prebypass Filter Gas Filter Pediatric Temp Probe

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set
Primary Device ID00607567203006
NIH Device Record Keyf48d6caf-9b99-4297-bfa7-8ba136a86351
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmall Patient Circuit
Version Model NumberBEQ-TOP 27901
Catalog Number701052287
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 Numbertrue
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
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
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
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
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
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
GS100607567203006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWETubing, Pump, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

[00607567203006]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-02
Device Publish Date2015-10-31

On-Brand Devices [Small Patient Circuit]

00607567203006BEQ-HMOD 30000 Soft Shell Venous Reservoir 800 Better Bladder 1/4 CDI Sat Cell Blood Microfilter
00607567212992BEQ-HMOD 30000-USA pediatric Quadrox iD, Softshell Venous Reser. 800ml, CDI Sat Cell 1/4" System
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