| Primary Device ID | 00850017460058 |
| NIH Device Record Key | 776adc13-de91-4c07-b893-a2859a20e534 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIOCOACH Glucose Control Solution L1/L2 |
| Version Model Number | S5800382 |
| Catalog Number | S5800382 |
| Company DUNS | 117225590 |
| Company Name | AMVENTUREX, INC. |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850017460058 [Primary] |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-05 |
| Device Publish Date | 2021-12-28 |
| 00850017460089 - BIOCOACH Blood Ketone Test Strips 50 Pack (Foil) | 2023-06-08 50s |
| 00850017460287 - BIOCOACH Blood Glucose Test Strips 50 Pack (Foil) | 2023-06-08 50s |
| 00850017460027 - BIOCOACH Blood Glucose Test Strips 50s | 2022-01-05 50s |
| 00850017460034 - BIOCOACH Blood Glucose and Ketone Monitoring System | 2022-01-05 Complete Kit |
| 00850017460058 - BIOCOACH Glucose Control Solution L1/L2 | 2022-01-05Level 1 & 2 |
| 00850017460058 - BIOCOACH Glucose Control Solution L1/L2 | 2022-01-05 Level 1 & 2 |
| 00850017460065 - BIOCOACH Blood Glucose Test Strips 25s | 2022-01-05 25s |
| 00860060002310 - KETOCOACH BLOOD KETONE METER | 2020-01-07 |
| 00860060002327 - KETOCOACH 50 BLOOD KETONE TEST STRIPS | 2020-01-07 |