NuMed Industries LLC.
Basic Information
- Brand Name
- NuMed Industries LLC.
- Primary DI
- 00819123010571
- Version / Model
- NM5050COL
- Company Name
- Numed Industries, LLC
- Labeler DUNS
- 964438910
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-04
- Public Version
- 1
- Public Version Date
- 2023-02-13
- Public Version Status
- New
- Public Device Record Key
- 44a0bd48-ff11-46a7-9e24-3582c846ee49
Device Description
Type I Collagen is the most abundant type of collagen in the human body. As the main component of connective tissue, it is the most abundant protein in mammals, making up from 25% to 35% of the whole-body protein content. Collagen, in the form of elongated fibrils, is mostly found in fibrous tissues such as tendons, bones, ligaments and skin. The fibroblast is the most common cell which creates collagen. During wound healing, collagen encourages the deposition and organization of newly formed collagen fibers and granulation tissue in the wound bed. It also stimulates new tissue development and wound debridement, creating an environment conducive to healing. NuMed Collagen Dressings are made of a porous type 1, 100% bovine collagen membrane. They consist of a fibrous collagen network similar to the dermis, creating an environment conducive to healing.
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48124 | Exudate-absorbent dressing, non-gel, antimicrobial | A wound covering intended to absorb exudates and blood from a wound (e.g., ulcers, burns, surgical wounds, lacerations, abrasions, and/or percutaneous device wounds), and that contains an antimicrobial agent [e.g., silver (Ag), chlorhexidine gluconate (CHG)]. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate. It is intended to create a moist wound-healing environment and/or protect wounds from external contamination by microorganisms from the periwound skin. 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 |
|---|---|---|---|---|---|---|
| Primary | 00819123010571 | GS1 | ||||
| Package | 10819123010578 | GS1 | Box | 5 | In Commercial Distribution | |
| Package | 20819123010575 | GS1 | Carton | 500 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 4.5 | Inch | |
| Width | 3.5 | Inch | |
| Depth | 1.5 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius