FDA UDI
In Commercial Distribution
🇺🇸 United States
Curity
DI: 10884521153103
·
Model: BT0605
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
144
Basic Information
- Brand Name
- Curity
- Primary DI
- 10884521153103
- Version / Model
- BT0605
- Catalog Number
- BT0605
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 144
- Record Status
- Published
- Publish Date
- 2018-06-29
- Public Version
- 4
- Public Version Date
- 2021-12-08
- Public Version Status
- Update
- Public Device Record Key
- f5885282-68be-4333-88d3-2a7a7715d360
Device Description
Elastic Bandage with Attached Clip
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
- No
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 10884521153103 | GS1 | ||||
| Unit of Use | 20884521153100 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 6 | Inch | |
| Device Size Text, specify | Length,5,Yard; |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- ;