DEVICE: SYSTEM 83 PLUS (SYSTEM83PLUS2)

Device Identifier (DI) Information

SYSTEM 83 PLUS
SYSTEM 83 PLUS 2
In Commercial Distribution

CUSTOM ULTRASONICS, INCORPORATED
SYSTEM83PLUS2
HIBCC

1
029526795 *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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Endoscope washer/disinfector A mains electricity (AC-powered) unit intended to be used for the washing and/or disinfecting of endoscopes with water or an appropriate disinfectant solution. It has built-in features to circulate a solution through the lumen (flushing) of the endoscope; some types may also have built-in drying features.
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FDA Product Code

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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

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Storage and Handling
Special Storage Condition, Specify: Keep Dry
Handling Environment Temperature: between 0 and 60 Degrees Fahrenheit
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

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Size Type Text
No Device Sizes
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Device Record Status

94e3e4b5-88e4-435e-b127-435fe35bd279
March 29, 2018
2
September 25, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B21583PLUS2 1 SYSTEM83PLUS2 In Commercial Distribution Corrugated Box
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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)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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