FDA UDI
In Commercial Distribution
🇺🇸 United States
Silicone Supra-Pubic Catheter (Ordinary Balloon)
DI: 04710961933472
·
Model: 1857-0212
·
FORTUNE MEDICAL INSTRUMENT CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Silicone Supra-Pubic Catheter (Ordinary Balloon)
- Primary DI
- 04710961933472
- Version / Model
- 1857-0212
- Company Name
- FORTUNE MEDICAL INSTRUMENT CORP.
- Labeler DUNS
- 656763489
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-03-15
- Public Version
- 4
- Public Version Date
- 2024-05-16
- Public Version Status
- Update
- Public Device Record Key
- f189c12b-53cd-4c13-8df9-5500f49fda88
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
- 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 |
|---|---|---|---|---|
| KOB | Catheter, Suprapubic (And Accessories) | Gastroenterology, Urology | 876.5090 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34924 | Suprapubic drainage catheter | A flexible/semi-rigid tube intended to be inserted through a suprapubic (above the pubic arch) incision directly into the bladder of a patient for the drainage of urine; it may also allow for infusion of fluid (e.g., medication, saline). It typically consists of a straight or angled, single-lumen tube with holes/tips at the distal end (e.g., malecot or pigtail design). The proximal end remains external to the patient and has a connector for connection to a urine collection device. It may include a stiffening device to assist in its insertion; however, it does not include non-dedicated supportive devices (i.e., not a kit). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04710961933472 | GS1 | ||||
| Unit of Use | 14710961933479 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K014002 | 000 |