FDA.reportPublic FDA data

AGILIA VP MC WIFI US

Primary DI
04086000856089
Brand
AGILIA VP MC WIFI US
Company
Fresenius Kabi AG
Model
Z019735
Catalog number
Z019735
Device description
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.
Published
2022-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
FRNPump, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210073000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210073000Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia DuoFresenius Kabi AG2022-03-01FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04086000856089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04086000856089040860008560894086000856089

GMDN Terms#

Term, Definition table
TermDefinition
Bedside infusion pumpAn electrically-powered, non-ambulatory (bedside) device designed to facilitate the accurate and consistent administration of drugs and solutions which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set; it is not dedicated to a specific treatment type. It is used to supply higher pressures than those provided by gravity infusion sets or infusion controllers (e.g., typical flow range of 1 to 999 ml/hour) and delivers solutions from a standard infusion bag or bottle of fluid. It is intended primarily for use at the bedside but typically has internal batteries that enable operation, e.g., during transportation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315654579
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811137013104Amicus Separator6R4590R6R4590R2026-03-11
00810020442229Amicus MNC Apheresis Kit - Double NeedleX7R2326SBX7R2326SB2026-02-03
01081002044222Amicus MNC Apheresis Kit - Double NeedleX7R2326SBX7R2326SB2026-02-03
04086000860888COMPOGUARD Advance Basic902974190297412024-10-30
04086000860895COMPOGUARD Advance Data902975190297512024-10-29
04086000860901COMPOGUARD Advance COMPLETE902976190297612024-10-29
04086000860741CompoGuard Basic (NA)902964190296412022-11-10
04086000860758CompoGuard Data (NA)902965190296512022-11-10
04086000860765CompoGuard Complete (NA)902966190296612022-11-10
04086000100199ALYX 2RBC LR KITX4R5720X4R57202018-02-14
04086000100991Fenwal AMICUS Apheresis Kit - Single Needle Functionally Closed4R23674R23672016-09-09
04086000100984Fenwal AMICUS Apheresis Kit - Double Needle Functionally Closed4R23654R23652016-09-09
00810020440164AMICUS Single Needle Advanced Kit with 20 mL Platelet Sampling System Assembly4R2353G4R2353G2020-10-20
04086000101370Fenwal AMICUS Single Needle Advanced Kit4R23534R23532016-09-02
04086000101387Fenwal AMICUS Double Needle Advanced Kit4R23544R23542016-09-02
00810020440140AMICUS Double Needle Advanced Kit with 20 mL Platelet Sampling System Assembly4R2354G4R2354G2020-10-20
04086000101332Fenwal AMICUS Apheresis Kit - Double Needle4R23554R23552016-09-09
04086000101349Fenwal AMICUS Apheresis Kit - Single Needle4R23574R23572016-09-09
04086000100090AMICUS Apheresis Kit – Single NeedleX6R2312X6R23122025-11-03
00810020441062Fenwal Hand Sealer4R4454W4R4454W2025-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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30815112021345Elution Test Vial Bracco Diagnostics Inc.FRN2024-02-13
10815112021396CardioGen-82 Infusion System Model 1700Bracco Diagnostics Inc.FRN2023-12-01
10815112021358CardioGen Patient Administration SetBracco Diagnostics Inc.FRN2023-10-16
17290109155149Sapphire Epidural Infusion Kit - US EITAN MEDICAL LTDFRN2023-09-05
30815112021338Accessory PackageBracco Diagnostics Inc.FRN2023-06-29
30815112020034Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
30815112020614Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
17290109154272Sapphire Epidural Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-15
17290109154289Sapphire M.T Infusion Pump Kit- US - S kit EITAN MEDICAL LTDFRN2022-05-15
17290109154265Sapphire M.T Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-11
10814844000365Curlin IV Pump SystemZEVEX INTERNATIONAL, INC.FRN2021-04-29
15019517177367PharmGuardICU MEDICAL, INC.FRN2020-03-20
15019517177374PharmGuardICU MEDICAL, INC.FRN2020-03-20
10884521064843KangarooCardinal Health, Inc.FRN2019-12-30
15019517155143MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517155150MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517155167MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517178067MedfusionICU MEDICAL, INC.FRN2019-09-18
20763000273334MiniMed™ ReservoirMEDTRONIC MINIMED, INC.FRN2019-09-02
20763000273358MiniMed™ ReservoirMEDTRONIC MINIMED, INC.FRN2019-09-02
M33513852011Plum 360ICU MEDICAL, INC.FRN2019-02-15
70643169771481MiniMed™ ReservoirMEDTRONIC MINIMED, INC.FRN2018-05-31
08050616611635APO-GO Syringe reservoirCANE' SPAFRN2018-05-28
17290109150229SapphirePlus Infusion Kit - USEITAN MEDICAL LTDFRN2018-02-22
09350902001614Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18
09350902001690Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18
09350902001720Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18
09350902001751Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18