FDA UDI
In Commercial Distribution
🇺🇸 United States
Coflex NL
DI: 10724004601922
·
Model: KIDSPACK 2" X 5 Yds
·
Andover Healthcare, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Coflex NL
- Primary DI
- 10724004601922
- Version / Model
- KIDSPACK 2" X 5 Yds
- Catalog Number
- 5200KP-036
- 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
- 434f66b3-8f28-4285-a3e0-4678c90af5e2
Device Description
CoFlex NL Cohesive Flexible Elastic Latex Free Bandage Compression Self Adherent Wrap KIDSPACK 2"X5 Yds
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
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 |
|---|---|---|---|---|
| 10284 | Pressure bandage, non-latex, single-use | A strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. 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 | 00724004601925 | GS1 | case | 36 | In Commercial Distribution | |
| Primary | 10724004601922 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 77 Degrees Fahrenheit