FDA UDI
In Commercial Distribution
🇺🇸 United States
S-Cath™
DI: 05055140701336
·
Model: 5760
·
MEDIPLUS LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- S-Cath™
- Primary DI
- 05055140701336
- Version / Model
- 5760
- Company Name
- MEDIPLUS LTD
- Labeler DUNS
- 228480810
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-17
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 4ea13179-74e1-407b-a1b1-f9106ff15efe
Device Description
S-Cath™ System - Silicone suprapubic Foley catheter, with introducer set, 12Fr. 10cc, 42cm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| KOB | CATHETER, SUPRAPUBIC (AND ACCESSORIES) | Gastroenterology, Urology | 876.5090 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34924 | Suprapubic drainage catheter | A sterile, flexible/semi-rigid tube intended to be inserted through a suprapubic (above the pubic arch) incision directly into the bladder of a male or female patient primarily for the drainage of urine, however it may also allow for infusion of fluid (e.g., medication, saline). It typically consists of a straight or angled, single-lumen tube which may have one of a variety of hole/tip configurations 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. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 15055140701333 | GS1 | Carton | 5 | In Commercial Distribution | |
| Primary | 05055140701336 | GS1 |
Customer Contacts
- Phone
- +4401494551200
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132890 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 42.0 | Centimeter | |
| Catheter Gauge | 12.0 | French |