FDA UDI
In Commercial Distribution
🇺🇸 United States
ENDURE INDUSTRIES
DI: 00840118617864
·
Model: UB2LA9
·
ENDURE INDUSTRIES
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- ENDURE INDUSTRIES
- Primary DI
- 00840118617864
- Version / Model
- UB2LA9
- Catalog Number
- UB2LA9
- Company Name
- ENDURE INDUSTRIES
- Labeler DUNS
- 066087031
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-17
- Public Version
- 1
- Public Version Date
- 2024-04-25
- Public Version Status
- New
- Public Device Record Key
- ba4681d5-8e3e-4101-9add-c07ce44387d5
Device Description
Luxury Urine Bag 2000 ml
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | Gastroenterology, Urology | 876.5250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58919 | Wearable adult urine collection bag, closed-ended | A flexible plastic pouch designed to connect to a urinary catheter and to be strapped to or worn on the leg of an adult/adolescent patient to collect discharged urine; it is not designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility and is disposed of when full. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00840118617871 | GS1 | Pack | 5 | In Commercial Distribution | |
| Primary | 00840118617864 | GS1 | ||||
| Package | 00840118618526 | GS1 | Pack | 10 | In Commercial Distribution | |
| Package | 00840118617888 | GS1 | Case | 100 | In Commercial Distribution |
Customer Contacts
- Phone
- 6072994971
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 49 Degrees Celsius