AGILIA VP MC WIFI US Z019735

GUDID 04086000856089

The Agilia VP Infusion System is intended for adult and pediatric care for the intermittent or continuous delivery of parenteral fluids, medications, 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 VP Infusion System is also intended for neonatal care for the intermittent or continuous delivery of parenteral fluids for hydration and nutrition, blood and blood derivatives through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, and subcutaneous using dedicated administration sets. It is intended for use by trained healthcare professionals in healthcare facilities.

Fresenius Kabi AG

Bedside infusion pump Bedside infusion pump Bedside infusion pump Bedside infusion pump Bedside infusion pump Bedside infusion pump Bedside infusion pump Bedside infusion pump Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel

• Primary Device ID: 04086000856089
• NIH Device Record Key: 684d8adf-065f-4cdb-b795-51843cdf4a8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AGILIA VP MC WIFI US
• Version Model Number: Z019735
• Catalog Number: Z019735
• Company DUNS: 315654579
• Company Name: Fresenius Kabi AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04086000856089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210073

FDA Product Code

• FRN: Pump, Infusion

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-29
• Device Publish Date: 2022-06-21

Devices Manufactured by Fresenius Kabi AG

• 00810020440591 - AMICUS Separator Legacy Software: 2024-04-04 Software version for AMICUS Separator Legacy Device
• 00810020440607 - AMICUS Separator Life Extension Software: 2024-04-04 Software version for AMICUS Separator Life Extension Device
• 04250273750164 - Volumat™ Line: 2024-03-29 IV administration set for infusion pumps
• 04250273750218 - Volumat™ Line: 2024-03-29 IV administration set for infusion pumps
• 04250273750287 - Volumat™ Line: 2024-03-29 IV administration set for infusion pumps
• 04250273750294 - Volumat™ Line: 2024-03-29 IV administration set for infusion pumps
• 10810020441632 - Amicus Apheresis Kit - Functionally Closed Single Needle with PAS Spike and Dual: 2024-02-01 For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Platelet Storage in Plasma or Platelet Additive Sol
• 10810020441649 - Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and Dual: 2024-02-01 For Extended Platelet Storage and Plasma Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. F