FDA UDI
In Commercial Distribution
🇺🇸 United States
Conveen
DI: 05708932135184
·
Model: 05050
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Conveen
- Primary DI
- 05708932135184
- Version / Model
- 05050
- Catalog Number
- 05050
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-17
- Public Version
- 2
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- ed413522-90f1-41aa-a28f-20633a5617b0
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
- 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
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNX | COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER | Gastroenterology, Urology | 876.5250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37685 | Personal device holder, reusable | A portable device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector, infusion pump) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a wearable bag, pouch, strap, belt, or clothing, or as a trolley with wheels. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00762123017197 | GS1 | Retail Box | 10 | In Commercial Distribution | |
| Primary | 05708932135184 | GS1 | ||||
| Package | 00762123017180 | GS1 | Shipper Box | 10 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 60 | Centimeter | |
| Device Size Text, specify | Length - in 23,6 |