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Certifications & Registrations

Delta's medical devices are FDA listed and safety certified by ETL. Only FDA registered facilities are legally allowed to manufacture blood refrigerators. The FDA requires that blood transport operators use only FDA listed blood refrigerators. Click these links to see the official registration on the FDA's own website. 

ISO 13485:2016

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Delta Development Team Inc. has been registered by Intertek, an MDSAP recognized auditing organization, as conforming to the requirements of ISO 13485:2016.

FDA Device Listing - APRU-6L

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The APRU-6L is a listed medical device with the U.S. Food & Drug Administration.

FAA Helicopter Air Ambulance Qualified - APRU-6L

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The APRU-6L meets Helicopter Air Ambulance (HAA) Equipment Requirements.

FDA Establishment Registration

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Delta Development Team Inc. is registered with the U.S. Food & Drug Administration. 

FEI Number: 3017667916

ETL Device Listing - APRU-6L

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The APRU-6L is certified to international medical device safety standards by Intertek.

FCC and ICES Declaration of Conformity - APRU-6L

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The APRU 6L meets USA CFR Title 21 Part 15B and Canada  ICES 003 for wireless 4.2 GHz module operation.

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