Identity
- Trade Name
- Tamper Evident Cap EUDAMEDeZSURE™ FDA UDI
- Generic Name
- Non-ISO80369-standardized fluid path protective cover FDA UDI
- Device Name
- Empty Fluid Container EUDAMEDTamper Evident Cap FDA UDI
- Model / Reference
- 426170 EUDAMEDFDA UDI
- Description
- Tamper Evident Cap FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18859299136179 EUDAMEDFDA UDI
- Basic UDI-DI
- 88592991B017UK EUDAMED
- Unit of Use DI
- 28859299136176 EUDAMED
- 510(k) Number
- K223674 FDA UDI
- FDA Product Code
- KPE FDA UDI
- EMDN Code
- A080299 INFUSION BAGS AND CONTAINERS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Non-ISO80369-standardized fluid path protective cover FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5025 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: Non-ISO80369-standardized fluid path protective cover
eZSURE™ 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 Non-ISO80369-standardized fluid path protective cover.
- BD PhaSeal — BD Switzerland Sàrl · Class II
- BD PhaSeal — BD Switzerland Sàrl · Class II
Cleared under the same submission
K223674 also covers:
- eZSURE™ — EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
- eZSURE™ — EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
- eZSURE™ — EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
- eZSURE™ — EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
- eZSURE™ — EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
- eZSURE™ — EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
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 |
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Manufacturer
- Manufacturer
- Epic International(thailand) Company Limited
Sources (2)
- FDA UDI f8420940-f0dc-40f5-937c-772beaf31a60 34 fields · synced Jul 9, 2026
- EUDAMED bbbf0f99-9add-4369-a865-de272591491c 61 fields · synced Jul 9, 2026