Identity
- Trade Name
- Sonostik Single Port ClearSafe Comfort Catheter FDA UDI
- Generic Name
- Central venous catheter inside-out introduction set FDA UDI
- Device Name
- Single Port ClearSafe Comfort, Closed Catheter 20G x 1.25” FDA UDI
- Model / Reference
- MS-87220 FDA UDI
- Description
- Single Port ClearSafe Comfort, Closed Catheter 20G x 1.25” FDA UDI
Identifiers
- Catalog Number
- Not Applicable FDA UDI
- Primary DI / UDI-DI
- 00840155410046 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Central venous catheter inside-out introduction set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 FDA UDI
- 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
Yes
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
Category: Central venous catheter inside-out introduction set
Sonostik Single Port ClearSafe Comfort Catheter by Medsource International Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Central venous catheter inside-out introduction set.
- Surfacer Inside-Out Access Catheter System — Bluegrass Vascular Technologies, Inc. · Class II
- Surfacer® — Merit Medical Systems, Inc. · Class II
- Sonostik Dual Port ClearSafe Comfort Catheter — MEDSOURCE INTERNATIONAL LLC · Class II
- Sonostik Single Port ClearSafe Catheter — MEDSOURCE INTERNATIONAL LLC · Class II
- Sonostik Dual Port ClearSafe Comfort Catheter — MEDSOURCE INTERNATIONAL LLC · Class II
- Sonostik Dual Port ClearSafe Catheter — MEDSOURCE INTERNATIONAL LLC · Class II
- Sonostik Dual Port ClearSafe Comfort Catheter — MEDSOURCE INTERNATIONAL LLC · Class II
- Sonostik Single Port ClearSafe Comfort Catheter — MEDSOURCE INTERNATIONAL LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medsource International Llc
Sources (1)
- FDA UDI a3e1af72-065d-4695-9bc0-0e01062d147d 34 fields · synced Jun 8, 2026