AGILIA SP MC WIFI US

Primary DI
04086000856058
Brand
AGILIA SP MC WIFI US
Company
Fresenius Kabi AG
Model
Z018735
Catalog number
Z018735
Device description
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
Published
2022-10-18
Public version status
New
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
K210074000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210074000Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB CableFresenius Kabi AG2022-03-01FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04086000856058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04086000856058040860008560584086000856058

GMDN Terms#

Term, Definition table
TermDefinition
Bedside syringe pumpA mains electricity (AC-powered) non-ambulatory device designed to precisely drive the plunger of a syringe down its barrel to infuse a solution when it must be administered with a high degree of volume accuracy and rate consistency. Because of the lower flow settings and flow resolution (e.g., 0.1 ml/hr), it is especially appropriate for neonatal, infant, and critical care applications in which small volumes of concentrated drugs are to be delivered over an extended period. It can also be used to administer epidural analgesia. It will typically have internal batteries to allow operation for a short period of time when no line power is available (e.g., during transport or a power outage).

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#

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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

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