Primary Device ID | B066201011000 |
NIH Device Record Key | b63f037d-5fe4-472c-af87-53b8222c97d4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Stopcock, TMP, 3Way w/luer |
Version Model Number | 201011-000 |
Catalog Number | 201011-000 |
Company DUNS | 938289980 |
Company Name | NOVOSCI CORP. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B066201011000 [Primary] |
HIBCC | B0662010110003 [Package] Package: INNER CARTON [25 Units] In Commercial Distribution |
HIBCC | B0662010110005 [Package] Package: CASE [100 Units] In Commercial Distribution |
HIBCC | B0662010110006 [Package] Package: PARTIAL CASE [50 Units] In Commercial Distribution |
HIBCC | B0662010110007 [Package] Package: PARTIAL CASE [75 Units] In Commercial Distribution |
DTZ | Oxygenator, Cardiopulmonary Bypass |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2015-09-14 |
B066C345B1 - CONNECTOR, EQUAL Y 1/2" W/LUER | 2023-07-13 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 LOCK | 2022-03-10 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 ADAPTER | 2022-03-10 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 LUER | 2022-03-10 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 LUER | 2022-03-10 A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension |
B066H11360 - STANDARD VAVD KIT | 2022-03-10 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/CLAMP | 2022-03-09 A sterile, semi-rigid tube used in open heart surgery to facilitate the transfer of priming fluids during the priming of the ext |