FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Provox Coming Home USA
DI: 07331791009334
·
Model: 8224US
·
Atos Medical AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Provox Coming Home USA
- Primary DI
- 07331791009334
- Version / Model
- 8224US
- Catalog Number
- 8224US
- Company Name
- Atos Medical AB
- Labeler DUNS
- 355470923
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-24
- Public Version
- 2
- Public Version Date
- 2023-06-14
- Public Version Status
- Update
- Public Device Record Key
- 427f7161-9130-4625-b3e5-6648a43fb8af
- Distribution End Date
- 2023-06-13
Device Description
Provox Coming Home/Provox Life Coming Home is an assortment of products and information for newly laryngectomized persons. It provides guidance on product use, lung rehabilitation, and stoma care at home.
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 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 |
|---|---|---|---|---|
| BYD | Condenser, Heat And Moisture (Artificial Nose) | Anesthesiology | 868.5375 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58705 | Tracheostoma protective filter | A non-sterile device designed as a filter for protecting a stomal opening in the windpipe (surgically-created artificial opening between the trachea and the body surface through which the patient can breathe) against harmful external influences. It may also function as a heat & moisture exchanger (HME) intended to capture the patient's exhaled breath so that it can be used to warm and moisten inspired air to help keep the trachea lubricated and prevent its mucosa from drying. It is typically designed as a hydrophobic foam filter of various sizes held in place with an adhesive strip. This is a single-use device changed regularly according to the manufacturer's instructions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07331791009334 | GS1 |
Customer Contacts
- Phone
- +4641519800
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 86 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Keep away from sunlight