| Primary Device ID | 04260647540314 |
| NIH Device Record Key | 146b4f7c-fea0-4545-8970-dc01296a8b4a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TECOtherm |
| Version Model Number | NEO |
| Catalog Number | 8289830 |
| Company DUNS | 315215424 |
| Company Name | Tec Com Medizintechnik 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 | false |
| Lot Batch | false |
| 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 |
| Phone | +493451205204 |
| service@TCM.GmbH | |
| Phone | +493451205204 |
| service@TCM.GmbH | |
| Phone | +493451205204 |
| service@TCM.GmbH | |
| Phone | +493451205204 |
| service@TCM.GmbH | |
| Phone | +493451205204 |
| service@TCM.GmbH | |
| Phone | +493451205204 |
| service@TCM.GmbH | |
| Phone | +493451205204 |
| service@TCM.GmbH | |
| Phone | +493451205204 |
| service@TCM.GmbH | |
| Phone | +493451205204 |
| service@TCM.GmbH | |
| Phone | +493451205204 |
| service@TCM.GmbH | |
| Phone | +493451205204 |
| service@TCM.GmbH |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260647540314 [Primary] |
| DWJ | System, Thermal Regulating |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-02 |
| Device Publish Date | 2024-04-24 |
| 04260647540277 - TECOtherm Wrabbit | 2024-10-10 The TECOtherm Wrabbit is designed as disposable device to help prevent postnatal heat and water loss in premature and newborn in |
| 04260647540215 - TECOtherm Wrabbit | 2024-10-10 The TECOtherm Wrabbit is designed as a disposable device to help prevent postnatal heat and water loss in premature and newborn |
| 04260647540260 - TECOtherm Wrabbit | 2024-10-10 The TECOtherm Wrabbit is designed as a disposable device to help prevent postnatal heat and water loss in premature and newborn |
| 04260647540314 - TECOtherm | 2024-05-02 |
| 04260647540314 - TECOtherm | 2024-05-02 |
| 04260647540031 - TCmatt | 2024-04-26 Mattress to be used with TECOtherm NEO hypothermia system for full body temperature control of patients, principally newborns an |
| 04260647540017 - TCmatt | 2020-11-30 Mattress to be used with TECOtherm NEO hypothermia system for full body temperature control of patients, principally newborns an |