Duns Number:796083392
Device Description: Measures water hardness in the range of: 0.0, 5, 10, 17, 50, 120 ppm.Each bottle contains Measures water hardness in the range of: 0.0, 5, 10, 17, 50, 120 ppm.Each bottle contains 50 test strips.
Catalog Number
K100-0102
Brand Name
Water Hardness Test Strip
Version/Model Number
K100-0102
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
Yes
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
JRS
Product Code Name
Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)
Public Device Record Key
68a7cc50-9b57-439e-8574-53224bf5ff43
Public Version Date
August 16, 2019
Public Version Number
2
DI Record Publish Date
June 18, 2019
Package DI Number
10858293006349
Quantity per Package
6
Contains DI Package
00858293006342
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |