Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)
Basic Information
- Brand Name
- Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)
- Primary DI
- 00792293773203
- Version / Model
- 77320
- Catalog Number
- 77320
- Company Name
- UROCARE PRODUCTS, INC.
- Labeler DUNS
- 070637129
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-10
- Public Version
- 7
- Public Version Date
- 2021-04-07
- Public Version Status
- Update
- Public Device Record Key
- 6a19ab2a-c3a0-4e90-9af2-ec179f4e4ac2
Device Description
BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, TWIST TYPE DRAIN VALVE, LARGE, 32 FL. OZ. (1,000 ML.) Uro-Safe® bags have the first ever, built-in, anti-reflux valve that is virtually self-cleaning and interference free... ensuring uninterrupted flow and problem free use. Because our anti-reflux valve is enclosed in a hard valve housing, it can't be held shut even when in sitting or reclining positions like other inferior products. Why settle for anything else? Uro-Safe® vinyl leg bags are for use with Foley® indwelling or male external catheters and urostomy drainage. Each Uro-Safe® bag is hand-tested for defect through each phase of manufacturing and packaged individually in a sterile, easy, peel-open pouch with two(2) “latex-free” leg straps. Features/Contains: Latex-Free, DEHP-Free, Anti-Reflux Valve Chamber, Clear Front with White Back for easy monitoring for blood or other substances in urine, "Latex-Free" Leg Straps with Buttons #60062 and Illustrated Application Instructions.
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | Gastroenterology, Urology | 876.5250 | 2 |
| 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 |
|---|---|---|---|---|---|---|
| Primary | 00792293773203 | GS1 | ||||
| Package | 20792293773207 | GS1 | Case | 168 | In Commercial Distribution | |
| Package | 10792293773200 | GS1 | Case | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- 909-621-6013
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 0.50 | Inch | |
| Weight | 0.14 | Pound | |
| Height | 15.00 | Inch | |
| Total Volume | 1000 | Milliliter | |
| Width | 5.25 | Inch | |
| Total Volume | 32 | Fluid Ounce |