Pediatric Specialty Pack 701062614R01

GUDID 00607567212800

BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 1900ml, Better Bladder 3/8, BEQ-RF32 RotaFlow, CDI Sat Cell 3/8" System 100, 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 ID00607567212800
NIH Device Record Keydcb7821c-c23f-4c92-8d7e-93028cf80e0a
Commercial Distribution Discontinuation2019-06-12
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePediatric Specialty Pack
Version Model NumberBEQ-TOP 2203
Catalog Number701062614R01
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
GS100607567212800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWETubing, Pump, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00607567212800]

Ethylene Oxide


[00607567212800]

Ethylene Oxide


[00607567212800]

Ethylene Oxide


[00607567212800]

Ethylene Oxide


[00607567212800]

Ethylene Oxide


[00607567212800]

Ethylene Oxide


[00607567212800]

Ethylene Oxide


[00607567212800]

Ethylene Oxide


[00607567212800]

Ethylene Oxide


[00607567212800]

Ethylene Oxide


[00607567212800]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-06-12
Device Publish Date2018-12-05

On-Brand Devices [Pediatric Specialty Pack]

00607567212800BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 1900ml, Better Bladder 3/8, BEQ-RF3
00607567206144BEQ-HMOD 70000 Softshell Venous Reser Better Bladder 3/8 BEQ-RF32 Rotaflow CDI Sat Cell 3/8 Syst
00607567204850BEQ HMOD 30000 Soft Shell Venous Reserv 800ml Better Bladder 1/4 Blood Microfilter Syst Prebypas
00607567204607BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, BEQ-RF32 RotaFlow, CDI Sat C

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