| Primary Device ID | 00385480127042 |
| NIH Device Record Key | bc276d37-579b-4361-b408-27e417df39f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NOVA/STAT PROFILE |
| Version Model Number | 1 |
| Catalog Number | 12704 |
| Company DUNS | 070617139 |
| Company Name | NOVA BIOMEDICAL CORPORATION |
| Device Count | 30 |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)545-6682 |
| info@novabio.com | |
| Phone | +1(800)545-6682 |
| info@novabio.com |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00385480127042 [Primary] |
| GS1 | 00385489127043 [Unit of Use] |
| JFP | ELECTRODE, ION SPECIFIC, CALCIUM |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-16 |
| 00385480205191 | STAT PROFILE pHOx/NOVA CO-OXIMETER CUVETTE WINDOW KIT |
| 00385480127042 | PREHEATER DEPROTEINIZING SOLUTION |