FDA UDI
In Commercial Distribution
🇺🇸 United States
Conveen Security+
DI: 00762123030196
·
Model: 21346
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
30
Basic Information
- Brand Name
- Conveen Security+
- Primary DI
- 00762123030196
- Version / Model
- 21346
- Catalog Number
- 21346
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2022-03-11
- Public Version
- 1
- Public Version Date
- 2022-03-21
- Public Version Status
- New
- Public Device Record Key
- 006c1d3f-b5a0-4732-a397-29ec9db1e5d0
Device Description
Conveen Security+. Urine collection bag. Bedside drainage bag. Inlet tube: 55 inch (140 cm). Two step outlet. incl. 1 x bag hanger. Volume 68 oz (2000 ml).
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NNW | BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE | Gastroenterology, Urology | 876.5250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58921 | Non-wearable adult urine collection bag, open-ended | A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00762123046814 | GS1 | Shipper Box | 4 | In Commercial Distribution | |
| Primary | 00762123030196 | GS1 | ||||
| Unit of Use | 05701780054645 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 68 | Fluid Ounce | |
| Length | 140 | Centimeter | |
| Total Volume | 2000 | Milliliter |