| Primary Device ID | 07331791002632 |
| NIH Device Record Key | 229af426-0c5a-4948-af60-7775305e98c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Provox FenestrationPunch |
| Version Model Number | 7654 |
| Catalog Number | 7654 |
| Company DUNS | 355470923 |
| Company Name | Atos Medical AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | |
| 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 | |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | 07331791002632 [Primary] |
| KTF | Punch, Ent |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07331791002632]
Moist Heat or Steam Sterilization
[07331791002632]
Moist Heat or Steam Sterilization
[07331791002632]
Moist Heat or Steam Sterilization
[07331791002632]
Moist Heat or Steam Sterilization
[07331791002632]
Moist Heat or Steam Sterilization
[07331791002632]
Moist Heat or Steam Sterilization
[07331791002632]
Moist Heat or Steam Sterilization
[07331791002632]
Moist Heat or Steam Sterilization
[07331791002632]
Moist Heat or Steam Sterilization
[07331791002632]
Moist Heat or Steam Sterilization
[07331791002632]
Moist Heat or Steam Sterilization
[07331791002632]
Moist Heat or Steam Sterilization
[07331791002632]
Moist Heat or Steam Sterilization
[07331791002632]
Moist Heat or Steam Sterilization
[07331791002632]
Moist Heat or Steam Sterilization
[07331791002632]
Moist Heat or Steam Sterilization
[07331791002632]
Moist Heat or Steam Sterilization
[07331791002632]
Moist Heat or Steam Sterilization
[07331791002632]
Moist Heat or Steam Sterilization
[07331791002632]
Moist Heat or Steam Sterilization
[07331791002632]
Moist Heat or Steam Sterilization
[07331791002632]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-05 |
| Device Publish Date | 2022-11-25 |
| 07331791181177 - Provox Dilator 17 | 2025-07-09 |
| 07331791181184 - Provox Dilator 20 | 2025-07-09 |
| 07331791181191 - Provox Dilator | 2025-02-17 |
| 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. |