Identity
- Trade Name
- ProSeal Injector Plus (DMA Compatible) EUDAMEDProSeal CSTD FDA UDI
- Generic Name
- Luer/Luer linear connector, single-use FDA UDI
- Device Name
- CSTD and Administration Devices EUDAMEDProSeal Injector Plus (DMA Compatible) FDA UDI
- Model / Reference
- 421050VT EUDAMEDFDA UDI
- Description
- ProSeal Injector Plus (DMA Compatible) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18859299124138 EUDAMEDFDA UDI
- Basic UDI-DI
- 88592991B014UD EUDAMED
- 510(k) Number
- K240171 FDA UDI
- FDA Product Code
- ONB FDA UDI
- EMDN Code
- A0704 SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS EUDAMED
- GMDN Term
- Luer/Luer linear connector, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Category: Luer/Luer linear connector, single-use
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 Luer/Luer linear connector, single-use.
- Medex — ICU MEDICAL, INC. · Class II
- BD PhaSeal — BECTON DICKINSON PEN LIMITED · Class II
- iLet Insulin Infusion Kit - Inset (23”, 6mm) 15-Pack (Pharmacy Kit) — Beta Bionics, Inc. · Class II
- Cook — COOK INCORPORATED · Class II
- Codan — CODAN US Corporation · Class II
- Medex — ICU MEDICAL, INC. · Class II
- Bioseal Inc. — BIOSEAL · Class I
- BD Syringe Filling Connector — BECTON DICKINSON AND COMPANY · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 7f5867d9-8f0d-4ab5-9bf5-12d5d1f49a3c 34 fields · synced Jun 19, 2026
- EUDAMED 30e4fd0b-4c2e-4780-b007-6e053f9de9d6 61 fields · synced Jun 19, 2026