Identity
- Trade Name
- ProSeal Bag Spike with Additive Port and Seal Tab (DMA Compatible) EUDAMEDProSeal CSTD FDA UDI
- Generic Name
- Non-ISO80369 formatted bag access spike FDA UDI
- Device Name
- CSTD and Administration Devices EUDAMEDProSeal Spike with Additive Port and Seal Tab (DMA Compatible) FDA UDI
- Model / Reference
- 423370ST EUDAMEDFDA UDI
- Description
- ProSeal Spike with Additive Port and Seal Tab (DMA Compatible) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18859299119950 EUDAMEDFDA UDI
- Basic UDI-DI
- 88592991B014UD EUDAMED
- 510(k) Number
- K251340 FDA UDI
- FDA Product Code
- ONB FDA UDI
- EMDN Code
- A070103 INFUSION TUBING ADAPTERS AND CONNECTORS EUDAMED
- GMDN Term
- Non-ISO80369 formatted bag access spike FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Market of Registration
- Cyprus 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: Non-ISO80369 formatted bag access spike
ProSeal CSTD by Epic International(thailand) Company Limited — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Non-ISO80369 formatted bag access spike.
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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 |
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Manufacturer
- Manufacturer
- Epic International(thailand) Company Limited
Sources (2)
- FDA UDI 8b7b32fc-2a09-4a6f-a408-2f013eac5ecb 34 fields · synced Jun 18, 2026
- EUDAMED 81d03bb1-e525-4056-8725-2fb0f3fc162f 61 fields · synced Jun 18, 2026