1/4" X 1/4" X 3/8" CLEAR PAY 321223-000

GUDID B0663212230007

A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by conne

NOVOSCI CORP.

Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use Non-ISO80369-standardized small-bore multichannel connector, single-use
Primary Device IDB0663212230007
NIH Device Record Keyd3e23d94-e92a-4ed2-b8f7-3ccdb500356c
Commercial Distribution StatusIn Commercial Distribution
Brand Name1/4" X 1/4" X 3/8" CLEAR PAY
Version Model Number321223-000
Catalog Number321223-000
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 Datefalse
Expiration Datetrue
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
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
HIBCCB0663212230000 [Primary]
HIBCCB0663212230003 [Package]
Contains: B0663212230000
Package: INNER CARTON [10 Units]
In Commercial Distribution
HIBCCB0663212230005 [Package]
Contains: B0663212230000
Package: CASE [40 Units]
In Commercial Distribution
HIBCCB0663212230006 [Package]
Contains: B0663212230000
Package: PARTIAL CASE [20 Units]
In Commercial Distribution
HIBCCB0663212230007 [Package]
Contains: B0663212230000
Package: PARTIAL CASE [30 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTLAdaptor, Stopcock, Manifold, Fitting, 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 Date2015-10-12

Devices Manufactured by NOVOSCI CORP.

B066C345B1 - CONNECTOR, EQUAL Y 1/2" W/LUER2023-07-13 A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension
B0662010110000 - STOPCOCK, TMP 3-WAY W/LUER LOCK2022-03-10 A general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durab
B0663010100000 - CONNECTOR, 3/8" PERFUSION ADAPTER2022-03-10 A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an e
B066341111NS1 - CONNECTOR, Y 3/16" x 3/16" x 3/16" 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
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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