Who else makes this device?

Name: RM3 Filter
Brand: RM3 Filter

RM3 Filter · System, Perfusion, Kidney → Gastroenterology & Urology

1manufacturer

1catalogue number

1510(k) clearance

1recall

Who Else Makes It

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

Chinese manufacturers registered for FDA product code KDN
Manufacturer	City	Province	Registered as	Device types
Sanbor Medical Xiamen, Inc.	Xiamen	Fujian	Contract manufacturer	16

Record

Regulatory record for RM3 Filter
Listed by	Waters Medical Systems, LLC, United States
FDA product code	KDN
Device type	System, Perfusion, Kidney
Device class	Class 2
Regulation	21 CFR 876.5880
Establishment	Complaint-file establishment, Manufacturer
510(k)	K971571
Record published	2017-02-12
Record revised	2019-03-21 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for RM3 Filter
Catalogue number	Size	Status
RM3 Filter		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
BAROguard	Paragonix Technologies, Inc.	7
LifePort® Kidney Transporter	Organ Recovery Systems, Inc.	5
KidneyVault	Paragonix Technologies, Inc.	5
KidneyVault Portable Renal Perfusion System	Paragonix Technologies, Inc.	3
PancreasPak	Paragonix Technologies, Inc.	3
Perfadex Plus®	Xvivo Perfusion AB	3
Perfusion Cannula	Institut Georges Lopez	3
Belzer UW Cold Storage Solution	Bridge to Life Ltd	3
Belzer UW Cold Storage Solution	Preservation Solutions, Inc.	3
X°Port Lung Preservation Solution	Traferox Technologies Inc.	3
LUNGguard	Paragonix Technologies, Inc.	2
Servator B Salf Solution	S.a.l.f. SPA Laboratorio Farmacologico	2

Showing 12 of 78. All products under System, Perfusion, Kidney

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K111521	2012-02-16

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. 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	Quantity	Closed
2022-03-21	Class II	Process control	There is a potential for the WCM cassette pump head leaking solution.	75 cases (6ct)	2024-08-16

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.

RM3 Filter