Duns Number:064468689
Device Description: A handheld, multi-function, digital device that measures conductivity, pH, Temperature, an A handheld, multi-function, digital device that measures conductivity, pH, Temperature, and ORP of water and dialysate fluids associated with hemodialysis delivery systems. It is used for monitoring the temperature conductivity and pH of dialysate and a Class II medical device. It can test both acetate and bicarbonate dialysate quality. It can also be used to test the quality of dialysis feed water. Internal sensors require the user to place the sample in the instrument, preventing contamination of dialysate by the measurement device. It is powered by a 9-volt battery. It’s FDA Product Code is FLB: Meter, Conductivity, Induction, Remote Type.
Catalog Number
D-6
Brand Name
Myron L® Company
Version/Model Number
D-6 Digital Dialysate Meter™
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K100237
Product Code
FLB
Product Code Name
Meter, Conductivity, Induction, Remote Type
Public Device Record Key
403e25e9-ca68-4269-af18-fccf604e6d03
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |