FDA UDI
In Commercial Distribution
🇺🇸 United States
Provox® ActiValve® Lubricant
DI: 07331791000515
·
Model: 7149
·
Atos Medical AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Provox® ActiValve® Lubricant
- Primary DI
- 07331791000515
- Version / Model
- 7149
- Company Name
- Atos Medical AB
- Labeler DUNS
- 355470923
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-11
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- ccf50c84-3d0a-47a8-a1c2-b10e3654ed54
Device Description
Provox ActiValve Lubricant shall be applied as a thin film on the inner lumen of Provox ActiValve voice prosthesis to help prevent occasional temporary blockage of the valve.
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 Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| EWL | Prosthesis, Laryngeal (Taub) | Ear, Nose, Throat | 874.3730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62094 | Tracheoesophageal speech valve, indwelling, non-sterile | A non-sterile device designed to be inserted into a surgically-created tracheoesophageal fistula after total laryngectomy to provide the patient with voice restoration. It is inserted and replaced as needed by a medical professional. It has a double flange (one on the outside of the throat and one on the inside) to hold it in place and includes a one-way valve that protects the airway during swallowing and opens under positive pressure so that air crosses into the oesophagus to produce voice (speech rehabilitation). It is routinely cleaned by the user in situ and assistive cleaning devices (e.g., brush) may be included. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07331791000515 | GS1 |
Customer Contacts
- Phone
- +4641519800
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092593 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 36 – 108 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Keep away from sunlight.