| Primary Device ID | B0664110090003 |
| NIH Device Record Key | 96c989ef-db06-4114-b643-fabf27d1677b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Goodwin Heart Line |
| Version Model Number | 411009-000 |
| Catalog Number | 411009-000 |
| Company DUNS | 938289980 |
| Company Name | NOVOSCI CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 800-854-0567 |
| info@novosci.com | |
| Phone | 800-854-0567 |
| info@novosci.com | |
| Phone | 800-854-0567 |
| info@novosci.com | |
| Phone | 800-854-0567 |
| info@novosci.com | |
| Phone | 800-854-0567 |
| info@novosci.com | |
| Phone | 800-854-0567 |
| info@novosci.com | |
| Phone | 800-854-0567 |
| info@novosci.com | |
| Phone | 800-854-0567 |
| info@novosci.com | |
| Phone | 800-854-0567 |
| info@novosci.com | |
| Phone | 800-854-0567 |
| info@novosci.com | |
| Phone | 800-854-0567 |
| info@novosci.com | |
| Phone | 800-854-0567 |
| info@novosci.com | |
| Phone | 800-854-0567 |
| info@novosci.com | |
| Phone | 800-854-0567 |
| info@novosci.com | |
| Phone | 800-854-0567 |
| info@novosci.com | |
| Phone | 800-854-0567 |
| info@novosci.com | |
| Phone | 800-854-0567 |
| info@novosci.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B0664110090000 [Primary] |
| HIBCC | B0664110090003 [Package] Contains: B0664110090000 Package: Case [10 Units] In Commercial Distribution |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-08 |
| Device Publish Date | 2019-02-05 |
| 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 |