FDA UDI
In Commercial Distribution
🇺🇸 United States
Coflex
DI: 10724004331027
·
Model: BLUE, 3"X 5 Yds
·
Andover Healthcare, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Coflex
- Primary DI
- 10724004331027
- Version / Model
- BLUE, 3"X 5 Yds
- Catalog Number
- 3300BL-024
- Company Name
- Andover Healthcare, Inc.
- Labeler DUNS
- 088528245
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-05
- Public Version
- 1
- Public Version Date
- 2022-04-13
- Public Version Status
- New
- Public Device Record Key
- 00605f89-724b-4c12-b782-3c3f1fca5d92
Device Description
CoFlex Self Adhering Compression Bandage, BLUE, 3"X 5 Yds
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FQM | Bandage, Elastic | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59015 | Pressure bandage, Hevea-latex, single-use | A strip or roll made of fabric with Hevea natural rubber latex (NRL) intended to be applied to and compress a local area of the body for various preventative/therapeutic applications (e.g., to stop bleeding, prevent oedema, provide support for varicose veins). The latex component is intended to create a bandage that clings to itself more than to skin so that compression can be maintained over longer periods. It is intended for use in the home or healthcare facility. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00724004331020 | GS1 | case | 24 | In Commercial Distribution | |
| Primary | 10724004331027 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 77 Degrees Fahrenheit