Duns Number:055252159
Device Description: Wall-mounted post-treatment for water purification for dialysis applications. Includes thr Wall-mounted post-treatment for water purification for dialysis applications. Includes three ultra-filters, particulate filter, DI header, two pumps, and divert-to-drain. 208V.
Catalog Number
WM-PST-255-RM-2GJ
Brand Name
POSTTREAT, 3UF, 208V, DTD
Version/Model Number
WM-PST-255-RM-2GJ
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
K920186
Product Code
FIP
Product Code Name
Subsystem, Water Purification
Public Device Record Key
d9460218-682b-4ac9-8cc4-efb7ceee86a8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 13, 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. | 77 |