| Primary Device ID | B0663010010000 |
| NIH Device Record Key | f27bdd6a-2497-4aa1-aad4-6d91daee8399 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FILTER, GAS/OXYGEN |
| Version Model Number | 301001-000 |
| Catalog Number | 301001-000 |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B0663010010000 [Primary] |
| HIBCC | B0663010010003 [Package] Package: INNER CARTON [10 Units] In Commercial Distribution |
| HIBCC | B0663010010005 [Package] Package: CASE [40 Units] In Commercial Distribution |
| HIBCC | B0663010010006 [Package] Package: PARTIAL CASE [20 Units] In Commercial Distribution |
| HIBCC | B0663010010007 [Package] Package: PARTIAL CASE [30 Units] In Commercial Distribution |
| KRI | Accessory Equipment, 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 | 2015-10-06 |
| B066301001NS1 | A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardio |
| B0663010010000 | A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardio |