FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 10888277678408
·
Model: URO25205V
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medline
- Primary DI
- 10888277678408
- Version / Model
- URO25205V
- Catalog Number
- URO25205V
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-05
- Public Version
- 2
- Public Version Date
- 2021-04-07
- Public Version Status
- Update
- Public Device Record Key
- bd4fbd42-63b8-4cf0-804f-d8b76849124a
Device Description
DRAINBAG, TOWER, L/F, LL,2000ML VENT
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
- 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 |
|---|---|---|---|---|
| KNX | COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER | Gastroenterology, Urology | 876.5250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45605 | Single-administration urethral catheterization kit, single-use | A sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device. | No | Active |
| 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 | 20888277678405 | GS1 | CASE | 20 | In Commercial Distribution | |
| Primary | 10888277678408 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 2000 | Milliliter |