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Wassenburg Medical, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30070822522523209Wassenburg Medical, Inc.1N2026-01-01144 Railroad Drive Ivyland PA US 18974

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860010835210Scope Assist Flushing Sink (SAFS) - A device use to flush endoscopes.215-364-1477info@wassenburgmedical.com
00860010835227Scope Assist Flushing Sink (SAFS) - Device to flush endoscopes215-364-1477info@wassenburgmedical.com
00860010835241System 83 Revolve - The System 83 Revolve® Endoscope Washer/Disinfector is an automated, computer controlled, electro-mechanical system intended to wash and high-level disinfect one or two submersible flexible endoscopes utilizing a detergent and FDA cleared high-level disinfectant validated by Wassenburg Medical. The System 83 Revolve® utilizes a processing chamber and the immersion method to perform washing, disinfection, rinsing, and alcohol flush of an endoscope to render a high-level disinfected endoscope. The System 83 Revolve® is capable of automated detergent dispensing and transfer of disinfectant solution between the reservoir and processing chamber. Following disinfection, the endoscopes and channels are automatically rinsed with potable water that is filtered through a water filtration system that contains a 0.1 micron bacteria filter and the channels are then flushed with air. A semi-automated air/alcohol flush must be completed at the end of the cycle. At completion, the operator prints out the endoscope reprocess215 364 1477info@wassenburgmedical.com
G434FLUSHINGSINKMODELS6Scope Assist Flushing Sink (SAFS) - A device use to flush endoscopes.215-364-1477info@wassenburgmedical.com
G434FLUSHINGSINKMODELS8Scope Assist Flushing Sink (SAFS) - Device to flush endoscopes215-364-1477info@wassenburgmedical.com
G434SYSTEM83PLUS2SYSTEM 83 PLUS - A device to disinfect endoscopes215-364-1477info@wassenburgmedical.com
G434SYSTEM83PLUS9SYSTEM 83 PLUS - A device to disinfect endoscopes215-364-1477info@wassenburgmedical.com
SYSTEM83PLUS9SYSTEM 83 PLUS - A device to disinfect endoscopes215-364-1477info@customultrasonics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
763291165118129K983017MODIFICATION TO SYSTEM 83 PLUSNVE1998-09-22
763291487862447K241168System 83 Revolve Endoscope Washer/DisinfectorFEB2024-12-19
763292030465672K173590System 83 Plus Washer/DisinfectorFEB2020-03-30
763291768752340K162120Scope-Assist Flushing SinkFEB2017-04-28
763291753926962K061430SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTORFEB2007-01-12
763291471777903
763291031908840
763292011332026

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FEB42024-12-19
NVE11998-09-22

PMN#

GUDID#