FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 10193489017670
·
Model: NON7919
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medline
- Primary DI
- 10193489017670
- Version / Model
- NON7919
- Catalog Number
- NON7919
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-22
- Public Version
- 2
- Public Version Date
- 2021-08-24
- Public Version Status
- Update
- Public Device Record Key
- 57efe497-f2dc-4450-adef-399821b1c142
Device Description
DRESSING,BURN,36"X36",16PLY,STERILE,LF
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAB | Gauze / sponge,nonresorbable for external use | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47692 | Cotton burn dressing, non-antimicrobial | A covering designed to treat small to large patient burns made of woven cotton impregnated with wound gel (e.g., hydrogel) and applied over the burn to protect against infection, minimize trauma and skin damage, moisten and cool the burn area, and prevent burn progression. It is available in various sizes (e.g., 1x1 m to 1x2 m), prefabricated shapes (e.g., vest) and may be body contoured; it does not include an antimicrobial agent(s). It is typically used by emergency medical services (EMS) and critical care units, but may also be used in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20193489017677 | GS1 | CASE | 30 | In Commercial Distribution | |
| Primary | 10193489017670 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight, Keep dry