Identity
- Trade Name
- pH/pCO2/pO2/Na/K/Ca Analyzer FDA UDI
- Generic Name
- Ion-selective analyser IVD FDA UDI
- Device Name
- EasyStat pH/pCO2/pO2/Na/K/Ca Analyzer FDA UDI
- Model / Reference
- 7005 FDA UDI
- Description
- EasyStat pH/pCO2/pO2/Na/K/Ca Analyzer FDA UDI
Identifiers
- Catalog Number
- 7005 FDA UDI
- Primary DI / UDI-DI
- 00386100003739 FDA UDI
- 510(k) Number
- K021515 FDA UDI
- FDA Product Code
- JFP FDA UDICEM FDA UDIJGS FDA UDIGKF FDA UDICHL FDA UDI
- GMDN Term
- Ion-selective analyser IVD 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ion-selective analyser IVD
pH/pCO2/pO2/Na/K/Ca Analyzer by Medica Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ion-selective analyser IVD.
- Sample supply unit — Roche Diagnostics Corp. · Class I
- cobas pro c 503 SBL-TL — Roche Diagnostics Corp. · Class I
- cobas pro e 801 SBL-DL — Roche Diagnostics Corp. · Class I
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Roche 9180 Electrolyte Analyzer — Roche Diagnostics Corp. · Class II
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- cobas pro c 503 SBL - DL — Roche Diagnostics Corp. · Class I
- cobas pro Sample Supply Unit — Roche Diagnostics Corp. · Class I
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.
- Reagent Module — Medica Corp.
- Sodium Electrode — 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 e3dbf205-f895-42d8-91a4-e01f1a37927b 37 fields · synced Jun 1, 2026