FDA UDI
In Commercial Distribution
🇺🇸 United States
ExtriCARE
DI: 04897089070088
·
Model: ST390-0002
·
ALLEVA MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ExtriCARE
- Primary DI
- 04897089070088
- Version / Model
- ST390-0002
- Catalog Number
- EC2400-MN-E
- Company Name
- ALLEVA MEDICAL LIMITED
- Labeler DUNS
- 669361099
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-05
- Public Version
- 1
- Public Version Date
- 2026-03-13
- Public Version Status
- New
- Public Device Record Key
- 3b26dd63-cf68-49d3-aa96-d17acab1668a
Device Description
Extricare Mini Oval Dressing
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
- Yes
- 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
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | 878.4780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47956 | Negative-pressure wound therapy system dressing set | A collection of devices that composes a sterile dressing pack used with the pump and collection container of a negative pressure wound therapy (NPWT) system to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic) and diabetic/pressure ulcers. It typically includes dressing (e.g., open-cell foam or medicated gauze), an airtight adhesive drape, a drain, an evacuation tube, and sterile saline. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14897089070085 | GS1 | Box | 15 | In Commercial Distribution | |
| Primary | 04897089070088 | GS1 | ||||
| Package | 24897089070082 | GS1 | Carton | 8 | In Commercial Distribution |