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MYRON L COMPANY · Model PortaKit for D-6 Digital Dialysate Meter · UDI-DI 00857744006221
8
510(k) clearances
3
Adverse events
2
Recalls
4
Facilities
Description
An accessory for the D-6 Dialysate Meter™. A hard case, foam-lined protective carrying case. Contains 1 (one) each 2 oz bottle of 14.0 millimohs, NaCl Standard Solution (P/N NACL-14.02OZ; UDI# 00857744006108). This is the only listed component included this item. The D-6 Dialysate Meter™ is packaged separately. NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predominately NaCI (sodium chloride), such as Dialysate. It’s FDA Product Code is FKH: Solution, Test Standard, Conductivity, Dialysis.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-12 | NIPRO Technical Services, Inc. | due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for dialysate. |
| 2017-05-12 | Mesa Laboratories, Inc. | Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet product specifications. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.