| Primary Device ID | 07331791016950 |
| NIH Device Record Key | 308d6039-926c-4c00-874a-c973b9a2bdc7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Provox Life Home HME |
| Version Model Number | 8311 |
| Catalog Number | 8311 |
| Company DUNS | 355470923 |
| Company Name | Atos Medical AB |
| Device Count | 30 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 | true |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 42 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07331791011405 [Primary] |
| GS1 | 07331791016950 [Unit of Use] |
| GS1 | 07331791017353 [Package] Contains: 07331791011405 Package: Shipper Box [50 Units] In Commercial Distribution |
| BYD | Condenser, Heat And Moisture (Artificial Nose) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-11-25 |
| Device Publish Date | 2022-12-07 |
| 07331791016905 - Provox Adhesive OptiDerm Round | 2024-11-29 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices |
| 07331791016929 - Provox XtraBase Adhesive | 2024-11-25 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices |
| 07331791016899 - Provox Adhesive FlexiDerm Plus | 2024-11-25 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices |
| 07331791016912 - Provox Adhesive OptiDerm Plus | 2024-11-25 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices |
| 07331791016943 - Provox Life Go HME | 2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma. |
| 07331791016950 - Provox Life Home HME | 2024-11-25Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma. |
| 07331791016950 - Provox Life Home HME | 2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma. |
| 07331791016967 - Provox Life Energy HME | 2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma. |
| 07331791016974 - Provox Life Protect HME | 2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma. |