| Primary Device ID | 05700699025647 |
| NIH Device Record Key | dad65a80-0d02-495a-b963-95a49aacb153 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | O2 module for the TCM4XX Series |
| Version Model Number | 902-564 |
| Catalog Number | 902-564 |
| Company DUNS | 308667539 |
| Company Name | Radiometer Medical ApS |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +459999999999 |
| radiometer@radiometer.dk |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05700699025647 [Primary] |
| LPP | Monitor, oxygen, cutaneous, for uses other than for infant not under gas anesthesia |
| 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 | 2016-09-01 |
| 55700699428764 - CLINITUBES D941G-NA-240-85X10 | 2023-04-20 D941G-NA-240-85x10 CLINITUBES 10 vials of 75 units, Multipack |
| 55700699044391 - CAPILLARY CAPS, RED 160pcs. | 2022-12-13 Capillary Caps, Red bag of 160 units |
| 55700699044537 - CAPILLARY CAPS, green 110pcs. | 2022-12-13 Capillary Caps, Green bag of 110 units |
| 55700699056615 - CLINITUBES D956G-70-35*1 | 2022-12-13 D956G-70-35x1 CLINITUBES 1 vial of 75 units. 35 µL. Multipack w. accessories |
| 55700699060223 - ABL77 CAPILLARY ADAPTERS | 2022-12-13 Capillary adaptor vented, 100 pcs. for ABL77 |
| 05700699339393 - AQURE NT Premium | 2022-12-13 AQURE NT Premium |
| 05700699339409 - AQURE NT Plus | 2022-12-13 AQURE NT Plus |
| 55700699428696 - CLINITUBES D957G-70-35X5 | 2022-12-13 D957G-70-35x5 CLINITUBES 5 vials of 75 units. 35 µL. Multipack w. accessories |