| Primary Device ID | 05099169297500 |
| NIH Device Record Key | b1039487-e5cf-46cc-ae53-c90023a97869 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BreathCO |
| Version Model Number | 2900 |
| Company DUNS | 219683489 |
| Company Name | VITALOGRAPH (IRELAND) LIMITED |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05099169297500 [Package] Contains: 15099196297501 Package: [1 Units] In Commercial Distribution |
| GS1 | 15099169297507 [Primary] |
| GS1 | 15099196297501 [Primary] |
| CCJ | ANALYZER, GAS, CARBON-MONOXIDE, GASEOUS-PHASE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-15 |
| 05099169297500 | BREATHCO MONITOR |
| 15099196297501 | BREATHCO MONITOR |