Identity
- Trade Name
- Reagent Module FDA UDI
- Generic Name
- Multiple electrolyte IVD, calibrator FDA UDI
- Device Name
- EasyStat Reagent Module FDA UDI
- Model / Reference
- 7101-0000 FDA UDI
- Description
- EasyStat Reagent Module FDA UDI
Identifiers
- Catalog Number
- 7101-0000 FDA UDI
- Primary DI / UDI-DI
- 00386100002664 FDA UDI
- 510(k) Number
- K021515 FDA UDI
- FDA Product Code
- JFP FDA UDICEM FDA UDIJGS FDA UDIGKF FDA UDICHL FDA UDI
- GMDN Term
- Multiple electrolyte IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1145 FDA UDI862.1600 FDA UDI862.1665 FDA UDI864.5600 FDA UDI862.1120 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
Reagent Module by Medica Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple electrolyte IVD, calibrator.
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC. · Class II
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC. · Class II
- Alinity — Abbott · Class II
- 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
K021515 also covers:
- Bi-Level QC Kit, HCT — Medica Corp.
- Calcium Electrode — Medica Corp.
- Daily Cleaning Solution Kit — Medica Corp.
- Potassium Electrode — Medica Corp.
- Sodium Electrode — Medica Corp.
- pH/pCO2/pO2/Na/K/Ca Analyzer — Medica Corp.
- pH/pCO2/pO2/Na/K/Ca Analyzer — Medica Corp.
- RAPIDChem® 700, RAPIDPoint® 340 Trouble shooting kit — Siemens Healthcare Diagnostics
- RAPIDPOINT® 340 Reagent Module — Siemens Healthcare Diagnostics
- RAPIDPOINT® 340 Sampler Module — Siemens Healthcare Diagnostics
- RAPIDPOINT® 340 Sensor Module — Siemens Healthcare Diagnostics
- RAPIDPOINT® 340/350 pO2 Electrode — Siemens Healthcare Diagnostics
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medica Corp.
Sources (1)
- FDA UDI 99eaa1de-6841-489e-99b8-548101189552 37 fields · synced May 30, 2026