FDA UDI
In Commercial Distribution
🇺🇸 United States
Algitocare alginate wound dressing
DI: 06934889085015
·
Model: AD05
·
QINGDAO BRIGHT MOON BIOMATERIALCO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Algitocare alginate wound dressing
- Primary DI
- 06934889085015
- Version / Model
- AD05
- Company Name
- QINGDAO BRIGHT MOON BIOMATERIALCO., LTD.
- Labeler DUNS
- 421362069
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-02
- Public Version
- 3
- Public Version Date
- 2022-11-08
- Public Version Status
- Update
- Public Device Record Key
- 27038f64-e1dd-4ddf-bc40-3764637889a8
- Distribution End Date
- 2025-08-01
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
- 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 |
|---|---|---|---|---|
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | 878.4018 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47474 | Exudate-absorbent dressing, hydrophilic-gel, antimicrobial | A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16934889085012 | GS1 | 10 | In Commercial Distribution | 2025-08-01 | |
| Primary | 06934889085015 | GS1 | ||||
| Package | 26934889085019 | GS1 | 40 | In Commercial Distribution | 2025-08-01 |