Open heart pack with NO VKMO 701066664

GUDID 00607567205925

BEQ-FR32 Rotaflow Prebypass filter Gas filter

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set
Primary Device ID00607567205925
NIH Device Record Key664be0c3-13db-4cac-bcf0-c8f11c861196
Commercial Distribution StatusIn Commercial Distribution
Brand NameOpen heart pack with NO VKMO
Version Model NumberBEQ-T 4903
Catalog Number701066664
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

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
GS100607567205925 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWETubing, Pump, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00607567205925]

Ethylene Oxide


[00607567205925]

Ethylene Oxide


[00607567205925]

Ethylene Oxide


[00607567205925]

Ethylene Oxide


[00607567205925]

Ethylene Oxide


[00607567205925]

Ethylene Oxide


[00607567205925]

Ethylene Oxide


[00607567205925]

Ethylene Oxide


[00607567205925]

Ethylene Oxide


[00607567205925]

Ethylene Oxide


[00607567205925]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-02
Device Publish Date2015-11-02

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