Small patient ECC Pack 701050175R01

GUDID 00607567208636

BEQ-HMOD 30000-USA Pediatric Quadrox iD Blood Transfer Bag 1000 ml - 2 spike ports BEQ-RF32 RotaFlow BMU Cell Ven. 1/4 Arterial Sensor 1/4" (BMU) Blood Microfilter System SQ 40 S Gas Filter Pediatric Temp Probe

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set
Primary Device ID00607567208636
NIH Device Record Keybdb2f2a1-8a22-4ab4-9cf7-ac56238c77c1
Commercial Distribution Discontinuation2017-04-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSmall patient ECC Pack
Version Model NumberBEQ-TOP 24100
Catalog Number701050175R01
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 Kitfalse
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
GS100607567208636 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWETubing, Pump, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00607567208636]

Ethylene Oxide


[00607567208636]

Ethylene Oxide


[00607567208636]

Ethylene Oxide


[00607567208636]

Ethylene Oxide


[00607567208636]

Ethylene Oxide


[00607567208636]

Ethylene Oxide


[00607567208636]

Ethylene Oxide


[00607567208636]

Ethylene Oxide


[00607567208636]

Ethylene Oxide


[00607567208636]

Ethylene Oxide


[00607567208636]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-02
Device Publish Date2016-01-29

On-Brand Devices [Small patient ECC Pack]

00607567212749BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 1/4, BEQ-RF32
00607567208865BEQ-HMOD 30000-USA Pediatric Quadrox iD Blood Transfer Bag 1000 ml - 2 spike ports BEQ-RF32 Rota
00607567208636BEQ-HMOD 30000-USA Pediatric Quadrox iD Blood Transfer Bag 1000 ml - 2 spike ports BEQ-RF32 Rota
00607567202504BEQ HMOD 30000 Blood Transfer Bag BEQ- RF32 CDI Sat cell Blood Microfilter system Gas Filter Ped
00607567202061BEQ- HMDOD 70000 Soft Shell Venous Reser 800mL Better Bladder 1/4 BEQ RF 32 Rotaflow Gas Filter
00607567213258BEQ-HMOD 30000-USA Pediatric Quadrox iD, Blood Transfer Bag 1000 ml - 2 spike ports,Blood Microf

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