FDA UDI
In Commercial Distribution
🇺🇸 United States
Urinary Catheter
DI: 10854913006119
·
Model: Urinary Catheter, 12 Fr
·
UROGEN PHARMA LTD
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Urinary Catheter
- Primary DI
- 10854913006119
- Version / Model
- Urinary Catheter, 12 Fr
- Catalog Number
- UC0005
- Company Name
- UROGEN PHARMA LTD
- Labeler DUNS
- 534155213
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-01
- Public Version
- 1
- Public Version Date
- 2022-06-09
- Public Version Status
- New
- Public Device Record Key
- 3f44168c-0882-4cda-92a0-0197c5934d5b
Device Description
The Urinary Catheter is a single use 12 Fr urethral catheter with a fixed female Luer lock hub. The catheter has a Coudé (Tiemann) tip, is 40 cm long and made of biocompatible soft PVC and is uncoated.
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| KOD | Catheter, Urological | Gastroenterology, Urology | 876.5130 | 2 |
| EZC | Catheter, Coude | Gastroenterology, Urology | 876.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45603 | Single-administration urethral drainage catheter | A sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20854913006116 | GS1 | carton | 10 | In Commercial Distribution | |
| Primary | 10854913006119 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211032 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Length | 40 | Centimeter | |
| Catheter Gauge | 12 | French |