ECC 3/8" Pump Pack

GUDID 00060756720531

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set
Primary Device ID00060756720531
NIH Device Record Key1c52bac5-f52d-4a64-86e2-059926e0e6e1
Commercial Distribution Discontinuation2018-05-23
Commercial Distribution StatusNot in Commercial Distribution
Brand NameECC 3/8" Pump Pack
Version Model NumberBEQ-TOP 41201
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18886278383
Emailcpsurgery@maquet.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100060756720531 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWETubing, Pump, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00060756720531]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-04-20

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00060756720531BEQ-TOP 41201
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