Who else makes this device?

Name: Perfadex Plus®
Brand: Perfadex Plus®

Gastroenterology & Urology › TherapeuticSystem, Perfusion, Kidney

Perfadex Plus®

Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is intended for the flushing, cold static storage and transportation of isolated lungs…

Registry build 21.09.26

Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is intended for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient. Package size: 10 x 1000ml

1manufacturer

3catalogue numbers in this listing

4510(k) clearances naming this product code

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 Perfadex Plus®
Listed by	Xvivo Perfusion AB, Sweden
FDA product code	KDN
Device type	System, Perfusion, Kidney
Device class	Class 2
Regulation	21 CFR 876.5880
Establishment	Specification developer, Complaint-file establishment, Manufacturer
Record published	2019-12-04
Record revised	2023-10-02 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, serial number
Storage	Storage environment temperature 2 to 25 °C
Distribution end date	2019-12-30

Catalogue Numbers

Catalogue numbers for Perfadex Plus®
Catalogue number	Size	Status
19950		In distribution
19900		Withdrawn
19800		Withdrawn

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
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
Waters IGL Cold Storage Solution	Institut Georges Lopez	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
K261644	2026-07-23
K211333	2022-01-20
K170826	2018-06-22
K091989	2010-10-01

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.