| Primary Device ID | 00385480504362 |
| NIH Device Record Key | 1846a72e-cafd-416d-be95-3d404ee19256 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StatStrip/StatSensor |
| Version Model Number | 1.0 |
| Catalog Number | 50436 |
| Company DUNS | 070617139 |
| Company Name | NOVA BIOMEDICAL CORPORATION |
| Device Count | 5 |
| 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 | false |
| Lot Batch | true |
| Serial Number | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00385480504362 [Primary] |
| GS1 | 00385489504363 [Unit of Use] |
| CGA | GLUCOSE OXIDASE, GLUCOSE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-08-09 |
| Device Publish Date | 2016-09-20 |
| 00385480636858 - StatStrip | 2024-04-05 StatStrip Glucose Hospital Meter System |
| 20385480534936 - NOVA | 2023-08-03 NOVA MAX PLUS KETONE TEST STRIPS |
| 00385480631648 - Nova Primary | 2023-03-06 Nova Primary Ampuled Control 1, 2 |
| 00385480631655 - Nova Primary | 2023-03-06 Nova Primary Linearity Level 1 |
| 00385480631662 - Nova Primary | 2023-03-06 Nova Primary Linearity Level 2 |
| 00385480632300 - Nova Primary | 2023-03-02 Nova Primary Glucose Membrane |
| 00385480631679 - Nova Primary | 2023-02-17 Nova Primary Calibrator Cartridge 150 Sample |
| 00385480632317 - Nova Primary | 2023-02-17 Nova Primary Glucose Sensor |