Duns Number:102530326
Device Description: Total Dissolved Solids Solution 150ppm 229uS/cm 1Pt
Catalog Number
02.0077
Brand Name
TDS Standard Solution
Version/Model Number
02.0077
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K191496,K191496
Product Code
FKH
Product Code Name
Solution-Test Standard-Conductivity, Dialysis
Public Device Record Key
a91e9d34-31cf-4b30-9f8b-c6c517a796a1
Public Version Date
May 12, 2020
Public Version Number
1
DI Record Publish Date
May 04, 2020
Package DI Number
M985020583
Quantity per Package
12
Contains DI Package
M985020077
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 29 |