Duns Number:315654579
Device Description: The Agilia SP Infusion System is intended for adult and pediatric care for the intermitten The Agilia SP Infusion System is intended for adult and pediatric care for the intermittent or continuous delivery of parenteral fluids, medication, blood, and blood derivatives through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, subcutaneous, and intraosseous using dedicated administration sets. The Agilia SP Infusion System is also intended for neonatal care for the intermittent or continuous delivery of parenteral fluids for hydration and nutrition, medication, blood, and blood derivatives through clinically accepted parenteral routes of administration and critical drugs under specific conditions. These routes of administration include intravenous, intraarterial, and subcutaneous using dedicated administration sets. It is intended for use by trained healthcare professionals in healthcare facilities
Catalog Number
Z018735
Brand Name
AGILIA SP MC WIFI US
Version/Model Number
Z018735
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K210074
Product Code
FRN
Product Code Name
Pump, Infusion
Public Device Record Key
c9ab036c-9742-42c1-9069-7ba37eacf8bc
Public Version Date
October 26, 2022
Public Version Number
1
DI Record Publish Date
October 18, 2022
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 |