Identity
- Trade Name
- eZSURE™ FDA UDI
- Generic Name
- Intravenous administration bag/bottle FDA UDI
- Device Name
- eZSURE™ Empty Fluid Container 250 ml Max Capacity FDA UDI
- Model / Reference
- 426040 FDA UDI
- Description
- eZSURE™ Empty Fluid Container 250 ml Max Capacity FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18859299136049 FDA UDI
- 510(k) Number
- K223674 FDA UDI
- FDA Product Code
- KPE FDA UDI
- GMDN Term
- Intravenous administration bag/bottle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5025 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
Yes
FDA UDI
Category: Intravenous administration bag/bottle
eZSURE™ by Epic International(thailand) Company Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravenous administration bag/bottle.
- Bag for enzyme replacement therapy — VALMED SRL · Class IIa
- Parenteral nutrition bag — VALMED SRL · Class IIa
- Parenteral nutrition bag — VALMED SRL · Class IIa
- Parenteral nutrition bag — VALMED SRL · Class IIa
- Parenteral nutrition bag — VALMED SRL · Class IIa
- SECURE® — METRIX COMPANY, THE · Class II
- Empty Fluid Container 250 ml Max Capacity (NFV Fill Port with Seal-Tab) — Epic International (Thailand) Co., Ltd. · Class I
- EVA TPN Bags — Valmed Corp. · 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 (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
- Epic International(thailand) Company Limited
Sources (1)
- FDA UDI c9da7e6c-7601-4001-8754-b9ad934b5bcd 34 fields · synced Jun 6, 2026