Filter, Gas/Oxygen 301001NS

GUDID B066301001NS1

A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potenti

NOVOSCI CORP.

Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line
Primary Device IDB066301001NS1
NIH Device Record Key780b9899-ed00-434d-b348-98a23043936b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFilter, Gas/Oxygen
Version Model Number301001NS
Catalog Number301001NS
Company DUNS938289980
Company NameNOVOSCI CORP.
Device Count500
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB066301001NS0 [Unit of Use]
HIBCCB066301001NS1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRIAccessory Equipment, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B066301001NS1]

Ethylene Oxide

[B066301001NS1]

Ethylene Oxide

[B066301001NS1]

Ethylene Oxide

[B066301001NS1]

Ethylene Oxide

[B066301001NS1]

Ethylene Oxide

[B066301001NS1]

Ethylene Oxide

[B066301001NS1]

Ethylene Oxide

[B066301001NS1]

Ethylene Oxide

[B066301001NS1]

Ethylene Oxide

[B066301001NS1]

Ethylene Oxide

[B066301001NS1]

Ethylene Oxide

[B066301001NS1]

Ethylene Oxide

[B066301001NS1]

Ethylene Oxide

[B066301001NS1]

Ethylene Oxide

[B066301001NS1]

Ethylene Oxide

[B066301001NS1]

Ethylene Oxide

[B066301001NS1]

Ethylene Oxide

[B066301001NS1]

Ethylene Oxide

[B066301001NS1]

Ethylene Oxide

[B066301001NS1]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-10-06

On-Brand Devices [Filter, Gas/Oxygen]

B066301001NS1A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardio
B0663010010000A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardio
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