FDA.reportPublic FDA data

SYSTEM 83 PLUS

Primary DI
SYSTEM83PLUS9
Brand
SYSTEM 83 PLUS
Company
Wassenburg Medical, Inc.
Model
SYSTEM 83 PLUS 9
Device description
A device to disinfect endoscopes
Published
2016-09-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FEBAccessories, Cleaning, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEBAccessories, Cleaning, For EndoscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B21583PLUS9PackageHIBCC1Not in Commercial Distribution
SYSTEM83PLUS9PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope washer-disinfector (chemical)An electrically-powered unit intended to be used for both washing and chemical disinfection of endoscopes, and their accessories. It has built-in features to circulate cleaning and disinfectant solutions through the lumen (flushing) of the endoscope; some types may also have built-in drying features. It is not intended for device sterilization.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius60 Degrees Celsius
Special Storage Condition, Specify00Do not fork lift
Special Storage Condition, Specify00Fragile
Special Storage Condition, Specify00Keep Dry

Contacts#

Phone, Email table
PhoneEmail
215-364-1477info@customultrasonics.com

Regulatory Flags#

DUNS number
118762097
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010835265Wassenburg Transport Cart TC-6TC-62024-04-23
STORAGECABINET20000Storage Cabinet200002021-09-07
DRY320DRY320DRY3202023-10-31
G434SC200001Storage Cabinet20000E001882023-07-27
G434FLUSHINGSINKMODELS6Scope Assist Flushing Sink (SAFS)S62023-08-11
G434FLUSHINGSINKMODELS8Scope Assist Flushing Sink (SAFS)S82023-08-11
SYSTEM83PLUS2SYSTEM 83 PLUSSYSTEM 83 PLUS 22016-09-25
FLUSHINGSINKMODELS6Scope Assist Flushing Sink (SAFS)S62017-05-16
FLUSHINGSINKMODELS8Scope Assist Flushing Sink (SAFS)S82017-05-16
00860010835241System 83 RevolveSystem 83 Revolve2025-02-24
00860010835203Storage Cabinet200002024-04-23
00860010835210Scope Assist Flushing Sink (SAFS)S62024-04-23
00860010835227Scope Assist Flushing Sink (SAFS)S82024-04-23
00860010835234DRY320DRY3202024-04-23
G434DRY320DRY320DRY3202023-10-31
G434SYSTEM83PLUS2SYSTEM 83 PLUSSYSTEM 83 PLUS 22023-08-15
G434SYSTEM83PLUS9SYSTEM 83 PLUSSYSTEM 83 PLUS 92023-08-11
G434TC61Wassenburg® Transport Cart TC-6TC-62023-07-06
PPS83S6Pre-Processing Sink83-S62017-10-31
PPS83S8Pre-Processing Sink83-S8 2017-10-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10724995245969Rapicide PA High-Level DisinfectantMEDIVATORS INC.FEB2026-03-06
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40677964054448Medivators HookupMEDIVATORS INC.FEB2025-04-04
40677964054622Medivators HookupMEDIVATORS INC.FEB2025-04-04
00860010835241System 83 RevolveWassenburg Medical, Inc.FEB2025-02-24
04260306710577SugiQuestAlpha GmbH & Co. KGFEB2024-12-02
04260306710584SugiQuestAlpha GmbH & Co. KGFEB2024-12-02
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