Duns Number:055252159
Device Description: Reverse osmosis device for water purification for dialysis applications. 2020 series, thre Reverse osmosis device for water purification for dialysis applications. 2020 series, three membranes, 208V.
Catalog Number
EQRMA-205K-3L
Brand Name
2020RO, 5400GPD, 208V, 3MEM
Version/Model Number
EQRMA-205K-3L
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
2b64cb69-bed1-4272-911c-9861f337b892
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 |