Goodwin Heart Line 411009-000

GUDID B0664110090003

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

NOVOSCI CORP.

Cardioplegia solution administration adaptor
Primary Device IDB0664110090003
NIH Device Record Key96c989ef-db06-4114-b643-fabf27d1677b
Commercial Distribution StatusIn Commercial Distribution
Brand NameGoodwin Heart Line
Version Model Number411009-000
Catalog Number411009-000
Company DUNS938289980
Company NameNOVOSCI CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Latextrue
RX Perscriptiontrue
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
HIBCCB0664110090000 [Primary]
HIBCCB0664110090003 [Package]
Contains: B0664110090000
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTRHeat-Exchanger, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-08
Device Publish Date2019-02-05

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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