| Primary Device ID | 00860394001270 |
| NIH Device Record Key | 613c72ec-3e04-4be6-8d57-b99f2533d1b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Curo A1c Analyzer |
| Version Model Number | Curo A1c Analyzer |
| Company DUNS | 087243403 |
| Company Name | KPI HEALTHCARE, INC. |
| 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 | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860394001270 [Primary] |
| CGA | Glucose Oxidase, Glucose |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-08-09 |
| Device Publish Date | 2019-04-26 |
| 00850006113026 - CURO A1c | 2019-08-09 CURO A1c Monthly Check Cartridge |
| 00850006113033 - CURO A1c | 2019-08-09 Curo A1c Test Cartridge |
| 00850006113040 - CURO A1c | 2019-08-09 CURO A1c Daily Check Cartridge |
| 00850006113064 - Curo L5 | 2019-08-09 CURO L5 Glucose Strip |
| 00860394001225 - CURO L5 | 2019-08-09 CURO L5 Cholesterol and Glucose measuring system |
| 00860394001232 - CURO B3 | 2019-08-09 CURO B3 Blood Pressure Monitor |
| 00860394001249 - CURO G6s Smart Glucose Meter | 2019-08-09 CURO G6s Smart Glucose Meter |
| 00860394001256 - CURO L5 Total Cholesterol Strips | 2019-08-09 Total Cholesterol Strips |