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.

BD Intelliport System · Infusion Safety Management Software → General Hospital

Name: BD Intelliport System
Brand: BD Intelliport System

1manufacturer

1catalogue number

1510(k) clearance

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 BD Intelliport System
Listed by	Becton, Dickinson AND Company, United States
FDA product code	PHC
Device type	Infusion Safety Management Software
Device class	Class 2
Regulation	21 CFR 880.5725
Establishment	Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer
Record published	2024-06-07
Record revised	2026-06-11 (version 2)

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 15 to 30 °C
Packaging	Carton of 24, case of 4
Distribution end date	2025-03-21

Catalogue Numbers

Catalogue numbers for BD Intelliport System
Catalogue number	Size	Status
516803		Withdrawn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
Alaris	CareFusion 303, Inc	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

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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K182092	2019-04-30

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.

BD Intelliport System