Agilia Link 8 Us

FDA UDI

Class II (US FDA UDI)

by Fresenius Kabi

Identity

Trade Name: AGILIA LINK 8 US FDA UDI
Generic Name: Intravenous pole multi-outlet holder FDA UDI
Device Name: Agilia Link 8 is an accessory to Agilia Infusion System as the stacking rack system intended to power and organize eight Agilia infusion pumps at the patient bedside. The Agilia Infusion System includes the Agilia Infusion Pump, which is a programmable electronic medical system dedicated to administering a pre-determined volume of an infusion product at a programmed rate, in combination with disposables and optional accessories. FDA UDI
Model / Reference: Z078135 FDA UDI
Description: Agilia Link 8 is an accessory to Agilia Infusion System as the stacking rack system intended to power and organize eight Agilia infusion pumps at the patient bedside. The Agilia Infusion System includes the Agilia Infusion Pump, which is a programmable electronic medical system dedicated to administering a pre-determined volume of an infusion product at a programmed rate, in combination with disposables and optional accessories. FDA UDI

Identifiers

Catalog Number: Z078135 FDA UDI
Primary DI / UDI-DI: 04086000856720 FDA UDI
510(k) Number: K210073 FDA UDI
FDA Product Code: MRZ FDA UDI
GMDN Term: Intravenous pole multi-outlet holder FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5725 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Intravenous pole multi-outlet holder

Agilia Link 8 Us by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K210073 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Fresenius Kabi

Sources (1)

FDA UDI 7f49de6f-6a0b-42ca-b21c-4f6c3b56c4b3 36 fields · synced Jun 8, 2026