FDA UDI
In Commercial Distribution
🇺🇸 United States
Leg Bag
DI: 00801741050992
·
Model: 650832
·
C. R. Bard, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Leg Bag
- Primary DI
- 00801741050992
- Version / Model
- 650832
- Catalog Number
- 650832
- Company Name
- C. R. Bard, Inc.
- Labeler DUNS
- 016898496
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-23
- Public Version
- 3
- Public Version Date
- 2021-04-07
- Public Version Status
- Update
- Public Device Record Key
- e7950913-f548-449b-89f5-80077e5aca13
Device Description
Dispoz-A-Bag Leg Bag, with Flip-Flo Drainage Valve, 2 Fabric Leg Straps and 18" Latex Extension Tubing, Large (32oz)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- 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 | 10801741050999 | GS1 | CA | 50 | In Commercial Distribution | |
| Primary | 00801741050992 | GS1 |
Customer Contacts
- Phone
- +1(800)526-4455
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 32 | Fluid Ounce |