Duns Number:064468689
Device Description: A handheld, analog instrument that measures conductivity of water and dialysate fluids ass A handheld, analog instrument that measures conductivity of water and dialysate fluids associated with hemodialysis delivery systems. It is used for monitoring the conductivity of dialysate and is a Class II medical device. The D-1 has an analog scale of 11-15 millimhos. It is powered by a 9-volt battery. It’s FDA Product Code is FLB: Meter, Conductivity, Induction, Remote Type.
Catalog Number
D-1
Brand Name
Myron L® Company
Version/Model Number
D-1 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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FLB
Product Code Name
Meter, Conductivity, Induction, Remote Type
Public Device Record Key
cd215697-074f-4ebc-83df-2b38bef62715
Public Version Date
March 29, 2018
Public Version Number
2
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 |