ECC 1/4" Pedi Pack w/o Better Blader 709000339

GUDID 00607567210490

BEQ-HMOD 30000-USA Pediatric Quadrox iD, Softshell Venous Reser. 1900ml, BEQ-RF32 RotaFlow, BMU Cell Ven. 1/4, Arterial Sensor 1/4" (BMU), Blood Micro

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set
Primary Device ID00607567210490
NIH Device Record Key13ea680c-428a-42c6-bf7d-d354ff7f9224
Commercial Distribution Discontinuation2018-05-23
Commercial Distribution StatusNot in Commercial Distribution
Brand NameECC 1/4" Pedi Pack w/o Better Blader
Version Model NumberBEQ-TOP 38900
Catalog Number709000339
Company DUNS001660786
Company NameDATASCOPE CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does n
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

Operating and Storage Conditions

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
GS100607567210490 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWETubing, Pump, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00607567210490]

Ethylene Oxide


[00607567210490]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-10-05

On-Brand Devices [ECC 1/4" Pedi Pack w/o Better Blader]

00607567210493BEQ-HMOD 30000-USA Pediatric Quadrox iD, Softshell Venous Reser. 1900ml, BEQ-RF32 RotaFlow, BMU
00607567210490BEQ-HMOD 30000-USA Pediatric Quadrox iD, Softshell Venous Reser. 1900ml, BEQ-RF32 RotaFlow, BMU

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