Adult ECC 701054295R02

GUDID 00607567213111

BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, CDI Sai 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 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 ID00607567213111
NIH Device Record Key8011f98a-b215-49bf-b41d-f8902378f7c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdult ECC
Version Model NumberBEQ-TOP 24202
Catalog Number701054295R02
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100607567213111 [Primary]

FDA Product Code

DWETubing, Pump, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00607567213111]

Ethylene Oxide


[00607567213111]

Ethylene Oxide


[00607567213111]

Ethylene Oxide


[00607567213111]

Ethylene Oxide


[00607567213111]

Ethylene Oxide


[00607567213111]

Ethylene Oxide


[00607567213111]

Ethylene Oxide


[00607567213111]

Ethylene Oxide


[00607567213111]

Ethylene Oxide


[00607567213111]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-23
Device Publish Date2019-05-15

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

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