Download GUDID

Leveraging GDSN for the FDA Global Unique Device Identifier Database (GUDID) Implementation Guideline
Population Guidance (below)
The GDSN attribute initialSterilirilizationPriorToUseCode is a code list indicating the type(s) of
sterilization which should be performed on a device by a Provider prior to use. Population of a value
for this attribute signifies that the device is not sold as sterile and that the Provider does need to
sterilize it prior to use, using the method populated. When this attribute is published, a value of
“TRUE” will be populated for the GUDID attribute Requires Sterilization Prior to Use. The value
specified will be provided to the GUDID as the Sterilization Method. It is recommended to not use
the value of UNSPECIFIED as the FDA GUDID will not accept that value.
Once published, a 7-day grace period begins. During the grace period, most attributes can be
edited. After the grace period ends on day 8, this attribute can be edited, but only under certain
circumstances. See Edit Rules After Grace Period for more details
Note: Until the GDSN release can add these code values into the sterilisationMethodCodeList
the GDSN AVP attribute for extendedInitialSterilzationPriorToUse can be used for them with
these code values: Chlorine_Dioxide, Dry_Heat, High_Intensity_Or_Pulse_Light,
Microwave_Radiation, Sound_Waves, High_Level_Disinfectant, Liquid_Chemical,
Nitrogen_Dioxide, and Supercritical_Carbon_Dioxide
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References
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For more information on UDI at a global level refer to http://www.gs1.org/healthcare/udi
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For more information on the IMDRF refer to http://www.imdrf.org/
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For more information on the U.S. FDA UDI refer to
http://www.gs1us.org/industries/healthcare/gs1-healthcare-us/fda-udi
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For more information on the GDSN refer to http://www.gs1.org/gdsn
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For more information on GS1 Healthcare refer to http://www.gs1.org/healthcare
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For country support contact your local GS1 Member Organisation http://www.gs1.org/contact
For an interactive spreadsheet of the mapping from GDSN to FDA GUDID refer to
http://www.gs1us.org/gs1-us-library?Command=Core_Download&EntryId=747
Release 2.0, Ratified, Oct 2015
© 2015 GS1 AISBL
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