Duns Number:796083392
Device Description: 6.8 - 8.5 pH Test Strips acid/bicarbonate dialysate 100/btl
Catalog Number
K100-0117
Brand Name
EZ-Chek
Version/Model Number
K100-0117
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K101750,K101750
Product Code
MNV
Product Code Name
Strip, Dialysate Ph Indicator
Public Device Record Key
18563702-1c38-40d8-8abe-a53f88b78b72
Public Version Date
August 16, 2019
Public Version Number
4
DI Record Publish Date
March 07, 2017
Package DI Number
10858293006134
Quantity per Package
5
Contains DI Package
00858293006137
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pack
| 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 |