What is FDA product code PHC?

Infusion safety management software is a prescription device intended for use with infusion pumps and may include one or more of the following capabilities: prepopulation of infusion programming parameters, data retrieval and analysis for tracking and trending, drug infusion error reduction algorithms, and alarm transmission.

Alaris · Infusion Safety Management Software → General Hospital

Name: Alaris
Brand: Alaris

1manufacturer

3catalogue numbers in this listing

3recalls on this code

Who Else Makes It

Registered in Shanghai. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PHC
Manufacturer	City	Province	Registered as	Device types
Jabil Circuit (Shanghai) Ltd.	Shanghai	Shanghai	Contract manufacturer	31

Record

Regulatory record for Alaris
Listed by	CareFusion 303, Inc, United States
FDA product code	PHC
Device type	Infusion Safety Management Software
Device class	Class 2
Regulation	21 CFR 880.5725
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K133532
Record published	2016-12-08
Record revised	2024-10-04 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number
Distribution end date	2023-07-21

Catalogue Numbers

Catalogue numbers for Alaris
Catalogue number	Size	Status
9601		In distribution
8975		Withdrawn
8961		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Ivenix Infusion System	Fresenius Kabi AB	6
BD Intelliport	Becton, Dickinson AND Company	5
PharmGuard	ICU Medical, Inc	4
LifeShield Infusion Safety Software Suite	ICU Medical, Inc	3
Dose IQ Safety Software	Baxter Healthcare Corporation	3
ICU Medical MedNet	ICU Medical, Inc	3
LifeShield Infusion Safety Software Suite – LifeShield CDR	ICU Medical, Inc	2
Alaris™ Guardrails™ Editor Software Kit, Model 8961	CareFusion 303, Inc	2
BD Alaris	CareFusion 303, Inc	1
BD Alaris™ System Manager 9601, Software	CareFusion 303, Inc	1
Vigilant Software Suite	Fresenius Kabi AB	1
BD Intelliport System	Becton, Dickinson AND Company	1

Showing 12 of 20. All products under Infusion Safety Management Software

Recalls Naming This Product

3 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.

Recalls naming the identifiers of Alaris
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
CareFusion 303, Inc	UDI-DI	2025-02-18	Class I	Under Investigation by firm	Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
CareFusion 303, Inc	UDI-DI	2024-05-21	Class II	Under Investigation by firm	Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server.	168 software version
CareFusion 303, Inc	510(k) number	2020-08-04	Class II	Vendor change control	Infusion pump component defect may result in interruption of patient monitoring	680 units

Recalls

1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason
2025-02-18	Class I	Under Investigation by firm	Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Alaris