Identity
- Trade Name
- PHOENIX DIAGNOSTICS, INC. FDA UDI
- Generic Name
- Multiple electrolyte IVD, calibrator FDA UDI
- Device Name
- Universal Cal Pack (Open) for Medica EasyLyte Series Electrolyte Systems FDA UDI
- Model / Reference
- 19-005 FDA UDI
- Description
- Universal Cal Pack (Open) for Medica EasyLyte Series Electrolyte Systems FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853366007578 FDA UDI
- FDA Product Code
- JIX FDA UDI
- GMDN Term
- Multiple electrolyte IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple electrolyte IVD, calibrator
Phoenix Diagnostics, Inc. by Phoenix Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- AU — Beckman Coulter, Inc. · Class II
- AU — Beckman Coulter, Inc. · Class II
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
- Phoenix Diagnostics, Inc.
Sources (1)
- FDA UDI 48c4541b-fdd5-465b-917e-55732e4a9add 33 fields · synced May 29, 2026