DEVICE: Auto Wash (10841736100704)

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Device Identifier (DI) Information

Auto Wash
J5-010-13
J5-010-13
SKYTRON LLC
10841736100704
GS1
1
Instrument Concentrate Solution, 5 gallon container with 61mm cap
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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

GMDN Preferred Term Name GMDN Definition
Medical device decontamination agent A non-sterile substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental, and/or surgical instruments/devices as part of the pre-cleaning and/or cleaning process to remove blood proteins and other organic compounds (decontamination) prior to disinfection or sterilization. It includes a detergent and may be added, as manufacturer specified, to water for cleaning procedures and/or be applied directly to soiled devices immediately after use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) intended to help facilitate cleaning. After application, this device cannot be reused.
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FDA Product Code

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Product Code Product Code Name
MEC Disinfector, medical devices
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
December 20, 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
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

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)759-8766
info@skytron.us
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