Sm Patient ECC Pack QPiD 701050839

GUDID 00607567201606

BEQ-HMOD 30000 Blood Transfer Bag 1000mL Better Bladder 1/4 BEQ RF 32 CDI Sat Cell 1/4" Prebypass Filter with out vent porous media 3/8 by 3/8 Pediatric Temp Probe

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set
Primary Device ID00607567201606
NIH Device Record Key0bff2244-97c7-4aaf-b056-dd53616d3af2
Commercial Distribution Discontinuation2019-10-26
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSm Patient ECC Pack QPiD
Version Model NumberBEQ-TOP 4901
Catalog Number701050839
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100607567201606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWETubing, Pump, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00607567201606]

Ethylene Oxide


[00607567201606]

Ethylene Oxide


[00607567201606]

Ethylene Oxide


[00607567201606]

Ethylene Oxide


[00607567201606]

Ethylene Oxide


[00607567201606]

Ethylene Oxide


[00607567201606]

Ethylene Oxide


[00607567201606]

Ethylene Oxide


[00607567201606]

Ethylene Oxide


[00607567201606]

Ethylene Oxide


[00607567201606]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-28
Device Publish Date2016-02-14

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