Duns Number:055252159
Device Description: Complete water purification system on a single platform with casters for dialysis applicat Complete water purification system on a single platform with casters for dialysis applications. Tank-feed, 2880 gallons per day, 115V. Includes the following components:- Pretreatment: carbon media tanks (carbon & polisher), water softener (tank and brine tank), particulate filtration, and UV light.- Reverse Osmosis device: 1232 series- Posttreatment: particulate filtration, and UV light- Other: disinfect tank, wall-mount divert-to-drain
Catalog Number
EQMEDIPAC-2880-TF-10
Brand Name
MEDIPAC, 2880GPD, TANK FEED, 115V
Version/Model Number
EQMEDIPAC-2880-TF-10
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
22b2a900-9387-4b5c-b9d9-81a19ed825bf
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 |