FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Provox Tracheofix
DI: 07331791012457
·
Model: 1 strip ivory 70x70
·
Atos Medical AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Provox Tracheofix
- Primary DI
- 07331791012457
- Version / Model
- 1 strip ivory 70x70
- Catalog Number
- 1428
- Company Name
- Atos Medical AB
- Labeler DUNS
- 355470923
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-07-12
- Public Version
- 2
- Public Version Date
- 2023-06-14
- Public Version Status
- Update
- Public Device Record Key
- fd5b3e1f-4db4-4846-87f4-c23ad29373c4
- Distribution End Date
- 2023-06-13
Device Description
Provox Tracheofix is a single-use foam protector intended to absorb secretions and to provide protection and aesthetic coverage of the tracheostoma.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | 878.4018 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63378 | Tracheostoma protector, single-use | A patient-worn device in the form of a self-adhesive patch designed to protect a tracheostoma orifice against harmful external influences and to absorb secretions; it may also act as a tracheal air filter. It is typically made of porous textile, foam or synthetic fabric materials; it is not intended to be used as a shower shield. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 07331791016820 | GS1 | ||||
| Primary | 07331791012457 | GS1 |
Customer Contacts
- Phone
- +4641519800
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 70 | Millimeter | |
| Width | 70 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Keep away from sunlight.
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 42 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 108 Degrees Fahrenheit