FDA UDI
In Commercial Distribution
🇺🇸 United States
Provox FreeHands Support Starter Set
DI: 07331791009266
·
Model: 8020
·
Atos Medical AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Provox FreeHands Support Starter Set
- Primary DI
- 07331791009266
- Version / Model
- 8020
- Catalog Number
- 8020
- Company Name
- Atos Medical AB
- Labeler DUNS
- 355470923
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-25
- Public Version
- 1
- Public Version Date
- 2022-12-05
- Public Version Status
- New
- Public Device Record Key
- 113b1f5f-c2a4-4a09-b691-0c58abf7b26b
Device Description
Provox FreeHands Support provides support to the Provox adhesive when using a Provox hands-free speaking valve after total laryngectomy. The device is a single patient use device with a single use adhesive.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- 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 |
|---|---|---|---|---|
| CBH | Device, Fixation, Tracheal Tube | Anesthesiology | 868.5770 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62155 | Tracheostomy base plate, reusable | A non-sterile flexible device designed to adhere to the skin around a tracheostoma to function as an anchor for a tracheostomal device (e.g., shower shield, hands-free speech valve). It is made of synthetic polymer and/or metal materials and is available in various forms (e.g., an annular disc with a slightly protruding hollow centre designed to accept the intended device, or a ring on a vertical support); it may include an adhesive backing or be intended to adhere with a separate medical adhesive or tape. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07331791009266 | GS1 |
Customer Contacts
- Phone
- +4641519800
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 42 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 108 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Keep away from sunlight