DEVICE: SYSTEM 83 PLUS (G434SYSTEM83PLUS2)

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Device Record History
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Device Identifier (DI) Information
SYSTEM 83 PLUS
SYSTEM 83 PLUS 2
In Commercial Distribution

Wassenburg Medical, Inc.
G434SYSTEM83PLUS2
HIBCC

1
118762097 *Terms of Use
A device to disinfect endoscopes
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
66649 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FEB Accessories, Cleaning, For Endoscope
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep Dry
Handling Environment Temperature: between 0 and 60 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Special Storage Condition, Specify: Do not fork lift
Special Storage Condition, Specify: Fragile
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
722d7eec-c061-4cd1-9ef4-a0c611af9574
August 23, 2023
1
August 15, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
215-364-1477
info@wassenburgmedical.com
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