FDA UDI
In Commercial Distribution
🇺🇸 United States
Dermacea
DI: 10884527015696
·
Model: 2263
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Dermacea
- Primary DI
- 10884527015696
- Version / Model
- 2263
- Catalog Number
- 2263
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-22
- Public Version
- 4
- Public Version Date
- 2021-12-08
- Public Version Status
- Update
- Public Device Record Key
- d6fa01a7-2e6b-40d7-b83b-3de40d4004bf
Device Description
Stretch Bandage
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
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 | 30884527015690 | GS1 | CASE | 48 | In Commercial Distribution | |
| Primary | 10884527015696 | GS1 | ||||
| Package | 20884527015693 | GS1 | PACK_OR_INNER_PACK | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 6 | Inch | |
| Length | 12.3 | Feet |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- This side up;