FDA UDI
In Commercial Distribution
🇺🇸 United States
GLOBAL HEALTHCARE
DI: 00872237004256
·
Model: UB-LE600
·
GHC HEALTHCARE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- GLOBAL HEALTHCARE
- Primary DI
- 00872237004256
- Version / Model
- UB-LE600
- Company Name
- GHC HEALTHCARE, INC.
- Labeler DUNS
- 884718776
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 6
- Public Version Date
- 2021-04-07
- Public Version Status
- Update
- Public Device Record Key
- c4b6fc0c-74be-4c8b-a10a-c5423cb1c3d2
Device Description
URINE BAG, 600ML, LEG BAG, ANTI REFLUX VALVE, ELASTIC STRAPS, FLUID PATHWAY STERILE.
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
- 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 |
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 | 40872237004254 | GS1 | CASE | 48 | In Commercial Distribution | |
| Primary | 00872237004256 | GS1 |