Adult ECC Pack 701049504R01

GUDID 00607567212589

BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 3/8, BEQ-RF32 RotaFlow, Gas Filter

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set
Primary Device ID00607567212589
NIH Device Record Key463b4956-f479-414f-9ca0-e152665e2a44
Commercial Distribution Discontinuation2019-06-12
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAdult ECC Pack
Version Model NumberBEQ-TOP 22300
Catalog Number701049504R01
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
GS100607567212589 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWETubing, Pump, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00607567212589]

Ethylene Oxide


[00607567212589]

Ethylene Oxide


[00607567212589]

Ethylene Oxide


[00607567212589]

Ethylene Oxide


[00607567212589]

Ethylene Oxide


[00607567212589]

Ethylene Oxide


[00607567212589]

Ethylene Oxide


[00607567212589]

Ethylene Oxide


[00607567212589]

Ethylene Oxide


[00607567212589]

Ethylene Oxide


[00607567212589]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-06-12
Device Publish Date2018-07-24

On-Brand Devices [Adult ECC Pack]

00607567212589BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 3/8, BEQ-RF32
00607567212466BEQ-HMOD 70000-USA Adult Quadrox iD, Blood Transfer Bag 1000 ml - 2 spike ports, BEQ-RF32 RotaFl
00607567212190BEQ-HMOD 70000-USA Adult Quadrox iD, BEQ-RF32 RotaFlow, BMU Cell Ven. 3/8, Arterial Sensor 3/8"
00607567211919BO-HMOD 70000-USA Adult Quadrox iD, BO-RF32 RotaFlow, Gas Filter
00607567211629BO-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 1900ml w. connector 700000292, BO-RF
00607567209169BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 1900ml w. connector 700000292, BEQ-
00607567208643BEQ-HMOD 70000-USA Adult Quadrox iD Blood Transfer Bag 1000 ml - 2 spike ports BEQ-RF32 RotaFlow
00607567207844BEQ HMOD 70000 BO VHK 31000 BO RF 32 SAT/CRIT Gas Filter
00607567206038BO-HMOD 700000 USA Adult Quadrox iD BO-RF32 RotaFlow Gas Filter
00607567205789BEQ-HMOD 70000 BEQ RF32 BMU Cell Arterial Sensor Gas Filter
00607567203396BO-HMOD 70000-USA Adult Quadrox iD BO-VHK 31000 Venous Res. Pediatric (MACE) BO-RF32 RotaFlow Ga
00607567203334BEQ-HMOD 70000 Gas Filter
00607567202511BEQ-HMOD 70000 Blood Transfer Bag 1000 BEQ RF32 Rotaflo CDI Sat CEll 3/8" Blood Microfilter Syst
00607567202306BEQ-HMOD 70000 Soft Shell Venous Reser 800 ml Better Bladder 3/8 BEQ-RF32 RotaFlow Gas Filter
00607567213012BEQ-HMOD 70000-USA Adult Quadrox iD, Venous Bag Reservoir 1900, BEQ-RF32 RotaFlow, Blood Microfi

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.