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.

Ivenix Infusion System · Infusion Safety Management Software → General Hospital

Name: Ivenix Infusion System
Brand: Ivenix Infusion System

1manufacturer

6catalogue numbers in this listing

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 Ivenix Infusion System
Listed by	Fresenius Kabi AB, Sweden
FDA product code	PHC
Device type	Infusion Safety Management Software
Device class	Class 2
Regulation	21 CFR 880.5725
Establishment	Contract manufacturer, Contract steriliser, Manufacturer
510(k)	K183311
Record published	2022-09-07
Record revised	2023-08-21 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number
Distribution end date	2023-07-19

Catalogue Numbers

Catalogue numbers for Ivenix Infusion System
Catalogue number	Size	Status
4.0.0		In distribution
030-0027-06		In distribution
030-0027-05		In distribution
3.0.0		In distribution
030-0027-07		In distribution
030-0027-05		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
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
BD Intelliport System	Becton, Dickinson AND Company	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
K210075	2022-03-01

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Ivenix Infusion System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Fresenius Kabi USA, LLC	510(k) number	2022-09-08	Class I	Software design	The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm	4 instances	2024-09-10
Fresenius Kabi USA, LLC	510(k) number	2022-04-22	Class II	Software design	Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.	1335 devices	2024-05-20

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.

Ivenix Infusion System