Duns Number:315654579
Device Description: The Agilia USB Cable is intended to connect the Agilia pumps from Fresenius Kabi to a comp The Agilia USB Cable is intended to connect the Agilia pumps from Fresenius Kabi to a computer with Fresenius Kabi maintenance or DERS software.
Catalog Number
Z073550
Brand Name
AGILIA USB CABLE US
Version/Model Number
Z073550
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K121613
Product Code
MRZ
Product Code Name
Accessories, Pump, Infusion
Public Device Record Key
9195e981-e903-48aa-9849-8c56156ae5d2
Public Version Date
November 08, 2021
Public Version Number
3
DI Record Publish Date
September 29, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |
| U | Unclassified | 2 |