Identity
- Trade Name
- ProSeal Inline Pump Set (DMA Compatible) EUDAMEDProSeal CSTD FDA UDI
- Generic Name
- Intravenous administration tubing extension set FDA UDI
- Device Name
- CSTD and Administration Devices EUDAMEDProSeal Inline Pump Set (DMA Compatible) FDA UDI
- Model / Reference
- 423850VT EUDAMEDFDA UDI
- Description
- ProSeal Inline Pump Set (DMA Compatible) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18859299124145 EUDAMEDFDA UDI
- Basic UDI-DI
- 88592991B014UD EUDAMED
- 510(k) Number
- K241735 FDA UDI
- FDA Product Code
- ONB FDA UDI
- EMDN Code
- A070103 INFUSION TUBING ADAPTERS AND CONNECTORS EUDAMED
- GMDN Term
- Intravenous administration tubing extension set FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
Yes
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Intravenous administration tubing extension set
ProSeal CSTD by Epic International(thailand) Company Limited — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Intravenous administration tubing extension set.
- VYGON — Vygon Corp. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- VYGON — Vygon Corp. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- BD MaxPlus — BD Switzerland Sàrl · Class II
- Statlock IV Select Start Kit — Bard Access Systems, Inc. · Class II
- Statlock IV — Bard Access Systems, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Epic International(thailand) Company Limited
Sources (2)
- FDA UDI be418296-7110-413c-a60f-6d5e0b3a7ab0 34 fields · synced Jun 18, 2026
- EUDAMED 888356f8-9a53-4df1-9db5-acc120b4c552 61 fields · synced Jun 18, 2026