Identity
- Trade Name
- Dialysis Calibrator FDA UDI
- Generic Name
- Multiple electrolyte IVD, calibrator FDA UDI
- Model / Reference
- 20-27-0483 FDA UDI
Identifiers
- Catalog Number
- 20-27-0483 FDA UDI
- Primary DI / UDI-DI
- 04580262010352 FDA UDI
- 510(k) Number
- K040958 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
No
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
Dialysis Calibrator by Tokyo Boeki Medisys Inc. — 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
- Alfa Wassermann — Alfa Wassermann, Inc.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC. · Class II
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC. · Class II
- Dimension® QuikLYTE® Integrated Multisensor Standard A — Siemens Healthcare Diagnostics · Class I
Cleared under the same submission
K040958 also covers:
- Calibrator 1 — TOKYO BOEKI MEDISYS INC.
- Calibrator 2 — TOKYO BOEKI MEDISYS INC.
- Calibrator 2 — TOKYO BOEKI MEDISYS INC.
- Calibrator SET A, B — TOKYO BOEKI MEDISYS INC.
- Cl (Chloride) Electrode — TOKYO BOEKI MEDISYS INC.
- K (Potassium) Electrode — TOKYO BOEKI MEDISYS INC.
- Na (Sodium) Electrode — TOKYO BOEKI MEDISYS INC.
- Urine Calibrator Set — TOKYO BOEKI MEDISYS INC.
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
- Tokyo Boeki Medisys Inc.
Sources (1)
- FDA UDI 2be0b26e-93b7-4fce-a254-48b4880a0c0e 36 fields · synced May 30, 2026