| Primary Device ID | 00365702128101 |
| NIH Device Record Key | b8fdba64-c825-4f08-ba45-611167ac3383 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoaguChek XS PT strips |
| Version Model Number | 4625315160 |
| Catalog Number | 4625315160 |
| Company DUNS | 315028860 |
| Company Name | Roche Diagnostics GmbH |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00365702128101 [Primary] |
| GJS | TEST, TIME, PROTHROMBIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-20 |
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