FDA UDI
In Commercial Distribution
🇺🇸 United States
Brava
DI: 05708932135252
·
Model: 4237.0
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Brava
- Primary DI
- 05708932135252
- Version / Model
- 4237.0
- Catalog Number
- 4237.0
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-05
- Public Version
- 1
- Public Version Date
- 2022-12-13
- Public Version Status
- New
- Public Device Record Key
- 8fa3a2f0-a0ae-4e7c-904a-44163fbc60a8
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| EXN | SUPPORT, HERNIA | Gastroenterology, Urology | 876.5970 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43370 | Ostomy bag pressure bandage | A piece, strip, or band of material designed to apply pressure to stabilize an ostomy bag (receptacle that collects bodily waste through a stoma) to a patient's body. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05708932565684 | GS1 | Retail Box | 15 | In Commercial Distribution | |
| Primary | 05708932135252 | GS1 | ||||
| Package | 05708932565691 | GS1 | Shipper Box | 8 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)533-0464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Descriptive Belt Size Standard |