FDA UDI
In Commercial Distribution
🇺🇸 United States
Provox Life Home HME Experience
DI: 07331791016103
·
Model: 8264
·
Atos Medical AB
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
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Basic Information
- Brand Name
- Provox Life Home HME Experience
- Primary DI
- 07331791016103
- Version / Model
- 8264
- Catalog Number
- 8264
- Company Name
- Atos Medical AB
- Labeler DUNS
- 355470923
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2024-06-21
- Public Version
- 4
- Public Version Date
- 2024-11-25
- Public Version Status
- Update
- Public Device Record Key
- 3e6271ec-05db-4193-bcdb-ca3d11cf7c2e
Device Description
Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a 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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 07331791017209 | GS1 | ||||
| Primary | 07331791016103 | GS1 | ||||
| Package | 07331791017483 | GS1 | Shipper Box | 50 | In Commercial Distribution |
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 away from rain. Keep away from sunlight.