| Primary Device ID | 00856522006095 |
| NIH Device Record Key | 2466f884-2a48-43a5-a13b-4f8a75048959 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Creatinine Control Kit |
| Version Model Number | 074446 |
| Catalog Number | 074402 |
| Company DUNS | 080886029 |
| Company Name | Lifehealth |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| 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 |
| Phone | 1-651-638-1000 |
| cs@lifehealthmed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856522006095 [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 | 2016-09-24 |
| 00856522006118 - CC Cartridge | 2018-05-24 Combo Cartridge, 10pk. |
| 00856522006125 - BG Cartridge | 2018-05-24 BG Cartridge, 10 pk |
| 00856522006132 - H3 Cartridge | 2018-05-24 H3 Cartridge, 10 Count |
| 00856522006002 - CC Cartridge | 2018-03-29 CC Cartridge, 25 count |
| 00856522006019 - BG Cartridge | 2018-03-29 BG Cartridge, 25 count |
| 00856522006026 - H3 Cartridge | 2018-03-29 H3 Cartridge, 25 count |
| 00856522006033 - H4 Cartridge | 2018-03-29 H4 Cartridge, 25 count |
| 00856522006040 - LA Cartridge | 2018-03-29 LA Cartridge, 25 count |