Duns Number:091381780
Device Description: TOP LEVEL ASSY, CM130
Catalog Number
9638600
Brand Name
HACH
Version/Model Number
9638600
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K162471
Product Code
FIP
Product Code Name
Subsystem, Water Purification
Public Device Record Key
0a22f752-eec1-4861-a6dd-30302559d492
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 12, 2017
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. | 10 |