Identity
- Trade Name
- NuMed Industries LLC. FDA UDI
- Generic Name
- Exudate-absorbent dressing, non-gel, antimicrobial FDA UDI
- Device Name
- NuMed Silver Alginate 4x5 Dressing, conformable wound dressings with a high mannuronic acid content. The silver impregnated alginate fibers, 1.4% w/w silver as silver calcium alginate per dressing, forms a gel when in contact with wound exudate or blood, which creates a moist wound healing environment. The silver in the alginate wound dressing has an antibacterial effect on various types of bacteria including; Staphylococcus aureus and E coli. The sustained release of silver ions protects the dressing from a broad spectrum of bacterial contamination over a period of up to 3 days. FDA UDI
- Model / Reference
- NM1012SAD FDA UDI
- Description
- NuMed Silver Alginate 4x5 Dressing, conformable wound dressings with a high mannuronic acid content. The silver impregnated alginate fibers, 1.4% w/w silver as silver calcium alginate per dressing, forms a gel when in contact with wound exudate or blood, which creates a moist wound healing environment. The silver in the alginate wound dressing has an antibacterial effect on various types of bacteria including; Staphylococcus aureus and E coli. The sustained release of silver ions protects the dressing from a broad spectrum of bacterial contamination over a period of up to 3 days. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20819123010544 FDA UDI
- 510(k) Number
- K120181 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Exudate-absorbent dressing, non-gel, antimicrobial FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 4 Inch FDA UDIWidth — 5 Inch FDA UDI
Category: Exudate-absorbent dressing, non-gel, antimicrobial
NuMed Industries LLC. by Numed Industries, LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K120181 also covers:
- Zeni Medical — FOCUS HEALTH GROUP
- Zeni Medical — FOCUS HEALTH GROUP
- Zeni Medical — FOCUS HEALTH GROUP
- Zeni Medical — FOCUS HEALTH GROUP
- Zeni Medical — FOCUS HEALTH GROUP
- Calcium Alginate Ag (Silver) Dressing (2x2 in) — Gentell
- Calcium Alginate Ag (Silver) Dressing (4x4 in) — Gentell
- Calcium Alginate Ag (Silver) Dressing (4x8 in) — Gentell
- Calcium Alginate Ag (Silver) Dressing (8x8 in) — Gentell
- Calcium Alginate Ag (Silver) Dressing Rope (12 in) — Gentell
- Calcium Alginate Ag Dressing 6"x6" — Gentell
- NuMed Industries LLC. — Numed Industries, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Numed Industries, LLC
Sources (1)
- FDA UDI a1d413eb-45b0-48c7-991c-4135d048b2f0 36 fields · synced May 30, 2026