Duns Number:393020474
Device Description: The DIACLEAR ultrafilter is intended to be used only with either HOSPAL Integra or Innova The DIACLEAR ultrafilter is intended to be used only with either HOSPAL Integra or Innova or GAMBRO Phonenix dialysis machines. It is indicated for purification of dialysis fluid to obtain microbiologically high quality dialysis fluid.
Catalog Number
106887
Brand Name
DIACLEAR
Version/Model Number
106887
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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"
Yes
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
K003957,K003957
Product Code
FIP
Product Code Name
SUBSYSTEM, WATER PURIFICATION
Public Device Record Key
df402d02-62f8-489c-93e0-af4d91712868
Public Version Date
October 11, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
37332414066315
Quantity per Package
12
Contains DI Package
07332414066314
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |