Identity
- Trade Name
- MF SAFECATH FDA UDI
- Generic Name
- Peripheral vascular intervention infusion catheter FDA UDI
- Model / Reference
- SC110 FDA UDI
Identifiers
- Catalog Number
- Intravascular catheter 16Gx1.77" FDA UDI
- Primary DI / UDI-DI
- 18800055100460 FDA UDI
- 510(k) Number
- FDA Product Code
- FOZ FDA 510(k)FDA UDI
- GMDN Term
- Peripheral vascular intervention infusion catheter FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 880.5200 FDA 510(k)
- Regulation Number
- 880.5200 FDA 510(k)FDA UDI
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Mf Safecath by Medifirst Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192230 | Class II | Active |
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Manufacturer
- Manufacturer
- Medifirst Co., Ltd.
Sources (2)
- FDA 510(k) K192230 24 fields · synced Jun 18, 2026
- FDA UDI b0fed885-2744-4978-9b9e-fa7c9fb83a59 34 fields · synced May 26, 2026