FDA UDI
In Commercial Distribution
🇺🇸 United States
ENDURE INDUSTRIES
DI: 00840118607346
·
Model: UB2TA8
·
ENDURE INDUSTRIES
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- ENDURE INDUSTRIES
- Primary DI
- 00840118607346
- Version / Model
- UB2TA8
- Catalog Number
- UB2TA8
- Company Name
- ENDURE INDUSTRIES
- Labeler DUNS
- 066087031
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-14
- Public Version
- 1
- Public Version Date
- 2023-10-23
- Public Version Status
- New
- Public Device Record Key
- 5e7128ab-6cb3-4e67-a562-03de28c930f3
Device Description
Urine Bag Adult, 2 L, T-Valve
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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EYZ | System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | Gastroenterology, Urology | 876.5250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58921 | Non-wearable adult urine collection bag, open-ended | A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00840118611930 | GS1 | Case | 5000 | In Commercial Distribution | |
| Primary | 00840118607346 | GS1 | ||||
| Package | 00840118615280 | GS1 | Box | 10 | In Commercial Distribution | |
| Package | 00840118615273 | GS1 | Box | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- 6072994971
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 49 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 49 Degrees Celsius