FDA UDI
In Commercial Distribution
🇺🇸 United States
Freevent Dressing Softfoam Slim L
DI: 07331791014109
·
Model: 8036
·
Atos Medical AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- Freevent Dressing Softfoam Slim L
- Primary DI
- 07331791014109
- Version / Model
- 8036
- Catalog Number
- 8036
- Company Name
- Atos Medical AB
- Labeler DUNS
- 355470923
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2025-10-24
- Public Version
- 1
- Public Version Date
- 2025-11-03
- Public Version Status
- New
- Public Device Record Key
- 93048a08-93db-46a5-b7ca-21139cf2547c
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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAD | Dressing, wound, occlusive | General, Plastic Surgery | 878.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15624 | Tracheostomy tube dressing | A pad designed to conform around a tracheostomy tube at its insertion site to provide protection for the skin and/or to absorb secretions. It is typically designed with a slit or hole to facilitate tube fitting. 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 | 07331791181306 | GS1 | ||||
| Primary | 07331791014109 | GS1 |
Customer Contacts
- Phone
- +4641519800
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU.
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 86 Degrees Fahrenheit