PRESSURE GUAGE ISOLATOR KIT 301400-000

GUDID B0663014000007

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
Primary Device IDB0663014000007
NIH Device Record Key81262ce7-628c-4254-8d2e-e3a8494ae5e3
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRESSURE GUAGE ISOLATOR KIT
Version Model Number301400-000
Catalog Number301400-000
Company DUNS938289980
Company NameNOVOSCI CORP.
Device Count1
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB0663014000000 [Primary]
HIBCCB0663014000003 [Package]
Contains: B0663014000000
Package: INNER CARTON [25 Units]
In Commercial Distribution
HIBCCB0663014000005 [Package]
Contains: B0663014000000
Package: CASE [100 Units]
In Commercial Distribution
HIBCCB0663014000006 [Package]
Contains: B0663014000000
Package: PARTIAL CASE [50 Units]
In Commercial Distribution
HIBCCB0663014000007 [Package]
Contains: B0663014000000
Package: PARTIAL CASE [75 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXSGauge, Pressure, Coronary, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-10-09

Devices Manufactured by NOVOSCI CORP.

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B066341222NS1 - CONNECTOR, Y 1/4" X 1/4" X 1/4"2022-03-10 A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension
B066341344NS5 - CONNECTOR, Y 3/8" x 1/2" x 1/2" W/O LUER2022-03-10 A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension
B066H11360 - STANDARD VAVD KIT2022-03-10 A collection of sterile devices intended to be used to inject cardioplegia solution into the heart to interrupt its contractions
B0663011240000 - QUICKIE PRIME - 24" W/CLAMP2022-03-09 A sterile, semi-rigid tube used in open heart surgery to facilitate the transfer of priming fluids during the priming of the ext
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