Alaris

FDA UDI

Class II (US FDA UDI)

by CareFusion 303, INC

Identity

Trade Name: Alaris FDA UDI
Generic Name: Bedside infusion pump, single-channel FDA UDI
Device Name: Alaris Pump Module FDA UDI
Model / Reference: 8100 FDA UDI
Description: Alaris Pump Module FDA UDI

Identifiers

Primary DI / UDI-DI: 10885403222054 FDA UDI
510(k) Number: K950419 FDA UDI
FDA Product Code: FRN FDA UDI
GMDN Term: Bedside infusion pump, single-channel 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

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Bedside infusion pump, single-channel

Alaris by CareFusion 303, INC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: CareFusion 303, INC

Sources (1)

FDA UDI ee14f9f3-b836-4932-9fdf-75e29f7e16a5 36 fields · synced May 30, 2026