FDA UDI
In Commercial Distribution
🇺🇸 United States
Brava
DI: 05708932728201
·
Model: 12032
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Brava
- Primary DI
- 05708932728201
- Version / Model
- 12032
- Catalog Number
- 12032
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-08
- Public Version
- 1
- Public Version Date
- 2022-04-18
- Public Version Status
- New
- Public Device Record Key
- 8d8efc2b-67ef-4620-bf55-eff495d6eab0
Device Description
Brava® Protective Seal . Feel Secure. Thickness 2.5 mm, Diameter Inner 3/4 in, Diameter Outer 3 in.
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
- MR Safe
- 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 |
|---|---|---|---|---|
| EXB | COLLECTOR, OSTOMY | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46207 | Peristomal/periwound dressing | A non-sterile substance or material intended to be applied to peristomal and/or periwound skin intended to protect it from body effluent (e.g., faeces, urine, wound exudate) and/or to help secure the seal of a stomal appliance or wound dressing. The device is typically available in a variety of forms including cream, paste in a tube or other applicator, paste in ready formed strips, or powder. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05708932721776 | GS1 | Shipper Box | 36 | In Commercial Distribution | |
| Package | 05708932721769 | GS1 | Retail Box | 10 | In Commercial Distribution | |
| Primary | 05708932728201 | GS1 |
Customer Contacts
- Phone
- +1(800)533-0464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 18 | Millimeter | |
| Outer Diameter | 76 | Millimeter | |
| Outer Diameter | 3 | Inch | |
| Device Size Text, specify | Thickness - mm 2.5 | ||
| Device Size Text, specify | Diameter Inner - in 3/4 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight.