Duns Number:032528935
Device Description: 130 Gallon Ultra-Pure Distribution System w/ Variable Frequency Control. Features: cal 130 Gallon Ultra-Pure Distribution System w/ Variable Frequency Control. Features: calibration scale, pedestal stand, 2-22 GPM flowmeter, electronic pressure transmitter, pressure guage, injection assembly, run dry protection, flow regulator, 316SS distribution pump (3Ph) 2 hp w/ VFD controller.
Catalog Number
-
Brand Name
Loop Distribution System
Version/Model Number
K-A-UPT-22B1A-130
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
67eef48e-3e8b-41ad-bbfc-d11f8d5a896d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
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 |