Duns Number:005146311
Device Description: Amia Automated PD Set with Cassette is used to deliver and drain solution to and from the Amia Automated PD Set with Cassette is used to deliver and drain solution to and from the peritoneal cavity during treatment.
Catalog Number
5C5479
Brand Name
Amia Automated PD Set with Cassette
Version/Model Number
5C5479
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
Yes
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
-
Product Code
FKX
Product Code Name
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Public Device Record Key
9d686438-815e-48d4-8c84-818e833f2ff1
Public Version Date
October 11, 2022
Public Version Number
3
DI Record Publish Date
October 12, 2015
Package DI Number
50085412153181
Quantity per Package
30
Contains DI Package
00085412153186
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 358 |