FDA UDI
In Commercial Distribution
🇺🇸 United States
ActivHeal
DI: 05032749024981
·
Model: Silver Moisture Wicking Fabric Silver
·
ADVANCED MEDICAL SOLUTIONS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ActivHeal
- Primary DI
- 05032749024981
- Version / Model
- Silver Moisture Wicking Fabric Silver
- Catalog Number
- 9024981
- Company Name
- ADVANCED MEDICAL SOLUTIONS LIMITED
- Labeler DUNS
- 770434090
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-27
- Public Version
- 1
- Public Version Date
- 2023-05-05
- Public Version Status
- New
- Public Device Record Key
- c4b9ff11-fafa-450d-93ec-45cd0585102e
Device Description
Moisture Wicking Fabric with Silver Dressing.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FRL | Fiber, Medical, Absorbent | General Hospital | 880.5300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62291 | Antimicrobial skin friction/moisture control fabric, single-patient reusable | A non-sterile absorbent textile material intended to be applied in skin folds or where skin-to-skin contact occurs (e.g., armpits, under the breasts, stomach, groin, and between fingers or toes) to prevent or reduce skin-to-skin friction, moisture, and irritation/inflammation; it is not intended to be used on open wounds. It is made of natural and/or synthetic materials and contains an antimicrobial agent [e.g., silver (Ag)]. This is a single-patient reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05032749024981 | GS1 |