Duns Number:032528935
Device Description: Concentrate Tank w/ Orange Pedestal, Vent Filter, Distribution System w/ Tank mounted Cont Concentrate Tank w/ Orange Pedestal, Vent Filter, Distribution System w/ Tank mounted Control box and Dry Run Protection
Catalog Number
-
Brand Name
Concentrate Distribution System
Version/Model Number
A-CDS-TANK-O
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 11, 2017
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
-
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
-
Product Code
FIP
Product Code Name
Subsystem, Water Purification
Public Device Record Key
287a8bdb-0ef5-406c-9dfe-f6506d3e0034
Public Version Date
May 15, 2018
Public Version Number
3
DI Record Publish Date
April 11, 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. | 264 |