Small Patient Tbg Pack SANS BLADDER 709000315

GUDID 00607567209992

Softshell Venous Reser. 1900ml, Blood Transfer Bag 1000 ml - 2 spike ports, BEQ-RF32 RotaFlow, Prebypass filter w/o Vent Porous Media 3/8x1/2, Gas Filter

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set
Primary Device ID00607567209992
NIH Device Record Key437281f4-5434-4700-bf1f-a7e8fc99f066
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmall Patient Tbg Pack SANS BLADDER
Version Model NumberBEQ-T 9407
Catalog Number709000315
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
GS100607567209992 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWETubing, Pump, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00607567209992]

Ethylene Oxide


[00607567209992]

Ethylene Oxide


[00607567209992]

Ethylene Oxide


[00607567209992]

Ethylene Oxide


[00607567209992]

Ethylene Oxide


[00607567209992]

Ethylene Oxide


[00607567209992]

Ethylene Oxide


[00607567209992]

Ethylene Oxide


[00607567209992]

Ethylene Oxide


[00607567209992]

Ethylene Oxide


[00607567209992]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-02
Device Publish Date2016-08-23

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