| Primary Device ID | 04719871820049 |
| NIH Device Record Key | 0eee8a05-f434-43a2-89e0-68100a3bd502 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | B T M |
| Version Model Number | 8228 |
| Company DUNS | 658447255 |
| Company Name | BIOTEST MEDICAL 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 | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 1-888-985-1125 |
| info@cmihealth.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04719871820049 [Primary] |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-03-02 |
| 04719871820315 - NuvoMed | 2018-04-09 NuvoMed Wireless Blood Glucose Monitoring System |
| 04719871820322 - NuvoMed | 2018-04-09 NuvoMed Wireless Glucose Monitor |
| 04719871820339 - NuvoMed | 2018-04-09 NuvoMed Glucose Test strip-25 pc |
| 04719871820001 - Smartest PersonaII | 2018-03-29 Smartest PersonaII Blood Glucose Monitoring System |
| 04719871820018 - Smartest PersonaII | 2018-03-29 Smartest Persona II Glucose Strip-25pcs |
| 04719871820025 - Smartest PersonaII | 2018-03-29 Smartest PersonaII Control Solution-M |
| 04719871820032 - Smartest PersonaII | 2018-03-29 Smartest PersonaII Glucose Meter |
| 04719871820049 - B T M | 2018-03-29Lancing Device |
| 04719871820049 - B T M | 2018-03-29 Lancing Device |