| Primary Device ID | 10385480534021 |
| NIH Device Record Key | da8bc3a7-eda3-48f3-a46d-5b8c381ba8e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StatSensor/StatStrip |
| Version Model Number | 1.75 |
| Catalog Number | 53402 |
| Company DUNS | 070617139 |
| Company Name | NOVA BIOMEDICAL CORPORATION |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 00385480534024 [Primary] |
| GS1 | 10385480534021 [Package] Contains: 00385480534024 Package: carton [1 Units] In Commercial Distribution |
| CGA | GLUCOSE OXIDASE, GLUCOSE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-08-09 |
| Device Publish Date | 2016-09-20 |
| 10385480560372 | StatStrip Docking Station Remanufactured 4 position 1.75 |
| 10385480560365 | StatStrip Docking Station Remanufactured 2 position 1.75 |
| 10385480544228 | StatStrip StatSensor Remanufactured Wireless Carrying Case for Meter and Supplies v1.0 |
| 10385480544198 | StatStrip StatSensor Remanufactured Wireless Carrying Case for Meter and Supplies |
| 10385480534397 | StatStrip StatSensor Wireless Carrying Case for Meter and Supplies |
| 10385480534021 | StatStrip StatSensor Docking Station |
| 10385480534014 | StatStrip StatSensor Docking Station |
| 10385480534007 | StatStrip StatSensor Docking Station |
| 10385480519967 | Statsensor Statstrip Docking Station 4 position |
| 10385480519950 | Statsensor Statstrip Docking Station 2 position |
| 10385480519943 | Statsensor Statstrip Docking Station |
| 10385480517567 | StatSensor StatStrip Docking Station Remanufactured |
| 10385480486306 | StatSensor StatStrip Wireless Carrying Case for Meter and Supplies |
| 10385480486290 | StatSensor StatStrip Docking Station for Wireless Carrying Case |
| 10385480438060 | StatSensor Stat Strip Docking Station Non Network Capable |
| 10385480422250 | StatSensor StatStrip Docking Station |