| Primary Device ID | 07331791015175 |
| NIH Device Record Key | ac21de6b-972f-4c48-9b1f-88ad37ac4ce2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Provox Life FreeHands FlexiVoice Set Plus |
| Version Model Number | 8210 |
| Catalog Number | 8210 |
| Company DUNS | 355470923 |
| Company Name | Atos Medical AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com |
| 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 dry. 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 dry. 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 dry. 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 dry. Keep away from sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07331791015175 [Primary] |
| EWL | Prosthesis, Laryngeal (Taub) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-15 |
| Device Publish Date | 2022-12-07 |
| 07331791017209 - Provox Life Home HME Experience | 2024-07-01 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma. |
| 07331791017216 - Provox Life Go HME Experience | 2024-07-01 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma. |
| 07331791014901 - Freevent XtraCare Mini White | 2023-12-12 Freevent XtraCare Mini is a single use Heat and Moisture Exchanger with electrostatic filter (HMEF) that condition and filter in |
| 07331791008023 - Provox StabiliBase (3pcs) | 2023-11-03 The Provox StabiliBase adhesive is a single use device intended for laryngectomized patients breathing through a tracheostoma. T |
| 07331791009044 - Provox StabiliBase OptiDerm (3pcs) | 2023-11-03 Provox StabiliBase OptiDerm adhesive is a single use device intended for laryngectomized patients breathing through a tracheosto |
| 07331791010293 - Provox XtraBase (3pcs) | 2023-11-03 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices |
| 07331791010309 - Provox FlexiDerm Round (3pcs) | 2023-11-03 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices |
| 07331791010316 - Provox FlexiDerm Oval (3pcs) | 2023-11-03 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices |