FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDLINE INDUSTRIES, INC.
DI: 10080196694068
·
Model: PRM25493
·
MEDLINE INDUSTRIES, INC.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MEDLINE INDUSTRIES, INC.
- Primary DI
- 10080196694068
- Version / Model
- PRM25493
- Catalog Number
- PRM25493
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-19
- Public Version
- 2
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- abe67840-1ee3-418a-8685-c0a0bcfd0e76
Device Description
BANDAGE,GAUZE,CONFORMING,3"X75",NS,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
- No
- 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 |
| FQM | BANDAGE, ELASTIC | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63661 | Non-woven gauze roll/sheet | A device in the form of a long length of stretchable, non-woven material (e.g., rayon/polyester), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20080196694065 | GS1 | BAG | 12 | In Commercial Distribution | |
| Primary | 10080196694068 | GS1 | ||||
| Package | 40080196694069 | GS1 | CARTON | 96 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]