FDA UDI
In Commercial Distribution
🇺🇸 United States
Dover
DI: 10192253028645
·
Model: 3433
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Dover
- Primary DI
- 10192253028645
- Version / Model
- 3433
- Catalog Number
- 3433-
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-04
- Public Version
- 1
- Public Version Date
- 2025-04-14
- Public Version Status
- New
- Public Device Record Key
- 6a2a29c6-288e-47d6-8f58-f289c8056e23
Device Description
URINE LEG BAG, 12" EXT. TUBE, A/R VALVE, TWIST VALVE, LF LEG STRAPS, MEDIUM, 17 OZ. (500 ML)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FAQ | BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE | Gastroenterology, Urology | 876.5250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58923 | Wearable adult urine collection bag, open-ended | A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter and to be strapped to or worn on the leg of an adult/adolescent patient to collect discharged urine; it is designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50192253028643 | GS1 | CASE | 50 | In Commercial Distribution | |
| Primary | 10192253028645 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 500 | Milliliter | |
| Length | 30.5 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity