1/4" X 1/2'" X 1/2" CLEAR PAY 321244-000

GUDID B0663212440007

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
Primary Device IDB0663212440007
NIH Device Record Keya1c5797d-3eb4-4553-aaf7-18af6e86b342
Commercial Distribution StatusIn Commercial Distribution
Brand Name1/4" X 1/2'" X 1/2" CLEAR PAY
Version Model Number321244-000
Catalog Number321244-000
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 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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB0663212440000 [Primary]
HIBCCB0663212440003 [Package]
Contains: B0663212440000
Package: INNER CARTON [10 Units]
In Commercial Distribution
HIBCCB0663212440005 [Package]
Contains: B0663212440000
Package: CASE [40 Units]
In Commercial Distribution
HIBCCB0663212440006 [Package]
Contains: B0663212440000
Package: PARTIAL CASE [20 Units]
In Commercial Distribution
HIBCCB0663212440007 [Package]
Contains: B0663212440000
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