Who else makes this device?

Name: Rapid Infuser Accessory Kit
Brand: Rapid Infuser Accessory Kit

General Hospital › TherapeuticPump, Infusion

Rapid Infuser Accessory Kit

Catalogue number 903-00013, listed by Belmont Instrument Corp., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26

5manufacturers in China registered for this device type

1catalogue number

5510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shanghai (2), Guangdong (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FRN
Manufacturer	City	Province	Registered as	Device types
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15
Dongguan Honfield Precision Parts Co., Ltd.	Zhangmutou, Dongguan	Guangdong	Contract manufacturer	8
JDI Electronics Factory	Dongguan	Guangdong	Contract manufacturer	7
Zyno Electric & Machinery Ltd, Shanghai	Shanghai	Shanghai	Contract manufacturer	1
Sterigenics Shanghai E Beam Ltd.	Shanghai	Shanghai	Contract manufacturer	14

Record

Regulatory record for Rapid Infuser Accessory Kit
Listed by	Belmont Instrument Corp., United States
FDA product code	FRN
Device type	Pump, Infusion
Device class	Class 2
Regulation	21 CFR 880.5725
510(k)	K091855
Record published	2016-09-24
Record revised	2023-11-08 (version 5)

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Rapid Infuser Accessory Kit
Catalogue number	Size	Status
903-00013		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Port Access Infusion SET	Sb-Kawasumi Laboratories, Inc.	76
Cadd	ICU Medical, Inc	56
Flow Control Tubing	GO Medical Industries PTY. Ltd.	39
Curlin Administration Set	Zevex, Inc.	30
ambIT	Summit Medical Products, Inc.	27
Beeline motIV	Rex Pj Tech LLC	24
RMS Precision Flow Rate TubingTM	Repro-Med Systems, Inc.	24
Medfusion	ICU Medical, Inc	24
Volumat™ Line	Fresenius Kabi AB	24
Outlook®	B. Braun Medical Inc.	21
Alaris	CareFusion 303, Inc	19
Alpha Source Battery	Alpha Source Inc.	17

Showing 12 of 191. All products under Pump, Infusion

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K141654	2014-07-18
K091855	2009-07-01
K992672	1999-08-24
K983975	1998-11-30
K972284	1997-11-13

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Rapid Infuser Accessory Kit
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Belmont Medical Technologies	510(k) number	2012-09-25	Class II	Device Design	Leak from a saline bag caused saline to drip along the back of the Rapid infuser close to the Power Entry Module causing an electrical flash at the power entry area.	2,913 units	2014-02-28

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.