| Primary Device ID | 00860060002334 |
| NIH Device Record Key | 105384e3-f7c1-4992-8482-c05967509ef5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KETOCOACH CONTROL SOLUTION Level 2 |
| Version Model Number | S5800335 |
| Company DUNS | 117225590 |
| Company Name | AMVENTUREX, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | 00860060002334 [Primary] |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-07 |
| Device Publish Date | 2019-12-30 |
| 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 | 2022-01-05 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 |