Waffle Grip Trendelenburg Positioning System a Hot Dog Patient Warming Accessory A300

GUDID 30855913001979

Individually Labeled: Waffle Grip Trendelenburg Positioning System, a Hot Dog Patient Warming Accessory A300 Box Labeled: Hot Dog Trendelenburg Positioning Kit Qty 10

AUGUSTINE TEMPERATURE MANAGEMENT LLC

Electric pad whole-body heating system

• Primary Device ID: 30855913001979
• NIH Device Record Key: 78074608-412d-4ae1-a677-f26110d28268
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Waffle Grip Trendelenburg Positioning System a Hot Dog Patient Warming Accessory
• Version Model Number: A300
• Catalog Number: A300
• Company DUNS: 965879187
• Company Name: AUGUSTINE TEMPERATURE MANAGEMENT LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 952-746-1720
• Email: cs@augbiomed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855913001978 [Primary]
GS1	30855913001979 [Package]; Contains: 00855913001978; Package: box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092807

FDA Product Code

• DWJ: System, Thermal Regulating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-28

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