Identity
- Trade Name
- Na/K Solution Pack FDA UDI
- Generic Name
- Multiple electrolyte IVD, calibrator FDA UDI
- Device Name
- Na/K Solution Pack for use with EasyLyte Analyzers FDA UDI
- Model / Reference
- 2109 FDA UDI
- Description
- Na/K Solution Pack for use with EasyLyte Analyzers FDA UDI
Identifiers
- Catalog Number
- 2109 FDA UDI
- Primary DI / UDI-DI
- 00386100003029 FDA UDI
- 510(k) Number
- K864872 FDA UDI
- FDA Product Code
- CEM FDA UDIJGS FDA UDI
- GMDN Term
- Multiple electrolyte IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1600 FDA UDI862.1665 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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: Multiple electrolyte IVD, calibrator
Na/K Solution Pack by Medica Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple electrolyte IVD, calibrator.
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- Electrolyte Standard Kit — VERICHEM LABORATORIES, INC. · Class II
- Calibrator 2 — TOKYO BOEKI MEDISYS INC. · Class II
- Alfa Wassermann — Alfa Wassermann, Inc.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC. · Class II
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC. · Class II
Cleared under the same submission
K864872 also covers:
- Bi-Level Quality Control Kit — Medica Corp.
- Capillary Adapter Cleaning Kit — Medica Corp.
- Capillary tubes — Medica Corp.
- Internal Filling Solution — Medica Corp.
- Membrane Assembly — Medica Corp.
- Na/K Analyzer — Medica Corp.
- Na/K Solution Pack — Medica Corp.
- Potassium Electrode — Medica Corp.
- Reference Electrode — Medica Corp.
- Sodium Electrode — Medica Corp.
- Tri-Level Quality Control Kit — Medica Corp.
- Wash Solution — Medica Corp.
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
- Medica Corp.
Sources (1)
- FDA UDI ace40dce-a03b-41a1-ba76-bf820f06f258 37 fields · synced May 30, 2026