Duns Number:005083209
Device Description: Homechoice Claria Automated Peritoneal Dialysis Cycler
Catalog Number
5C6M40
Brand Name
Homechoice Claria
Version/Model Number
5C6M40
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"
-
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
K201867,K201867
Product Code
FKX
Product Code Name
System, peritoneal, automatic delivery
Public Device Record Key
01893c09-cf88-4abc-82dd-e44e065ebea9
Public Version Date
October 11, 2022
Public Version Number
2
DI Record Publish Date
December 01, 2020
Package DI Number
50085412676468
Quantity per Package
1
Contains DI Package
00085412676463
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |
| 3 | A medical device with high risk that requires premarket approval | 19 |