Duns Number:032528935
Device Description: 250 Gallon Ultra-Pure Distribution System w/ Variable Frequency Control. Features: cal 250 Gallon Ultra-Pure Distribution System w/ Variable Frequency Control. Features: calibration scale, pedestal stand, Digital flow monitor w/ velocity readout, Loop conductivity monitor with set-point, Disinfect mode, digital pressure transmitter, sanitary sampling port, injection assembly, run dry protection, flow regulator, 316 SS distribution pump (3Ph) 2 hp w/ VFD controller.
Catalog Number
-
Brand Name
Loop Distribution System
Version/Model Number
K-A-UPT-22B1A-X-D
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
-
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
2167b320-ff47-46bd-8576-2b3a04bb601a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 05, 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 |