FDA UDI
In Commercial Distribution
🇺🇸 United States
Provox Life Oxygen (10 pcs)
DI: 07331791018107
·
Model: 7620
·
Atos Medical AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Provox Life Oxygen (10 pcs)
- Primary DI
- 07331791018107
- Version / Model
- 7620
- Catalog Number
- 7620
- Company Name
- Atos Medical AB
- Labeler DUNS
- 355470923
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2025-12-16
- Public Version
- 1
- Public Version Date
- 2025-12-24
- Public Version Status
- New
- Public Device Record Key
- 75b2792e-b562-4c25-9340-b6fca056b883
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| 67419 | Tracheostoma device adaptor, single-use | A noninvasive device intended to be used in the home and clinical settings by a person breathing through a tracheostoma to facilitate the connection of a device at the tracheostoma, on the skin side [e.g., heat and moisture exchanger (HME), oxygen administration cannula]. It is typically in the form of a ring or shallow hollow cylinder; some types have an integrated port to enable connection to respiratory gas tubing. It is not a tracheostomy mask (i.e., does not create a semi-tight enclosure around the tracheostoma). 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 | 07331791181153 | GS1 | ||||
| Primary | 07331791018107 | GS1 |
Customer Contacts
- Phone
- +4641519800
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from rain. Keep away from sunlight.