HotDog Universal Warming Blanket B500

GUDID 00855913001992

HotDog Universal Warming Blanket

AUGUSTINE TEMPERATURE MANAGEMENT LLC

Electric pad whole-body heating system Electric pad whole-body heating system Electric pad whole-body heating system Electric pad whole-body heating system Electric pad whole-body heating system Electric pad whole-body heating system Electric pad whole-body heating system Electric pad whole-body heating system Electric pad whole-body heating system Electric pad whole-body heating system Electric pad whole-body heating system Electric pad whole-body heating system Electric pad whole-body heating system Electric pad whole-body heating system Electric pad whole-body heating system

• Primary Device ID: 00855913001992
• NIH Device Record Key: 2155f7f3-1792-41b4-9312-3aec3e0d2938
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HotDog Universal Warming Blanket
• Version Model Number: B500
• Catalog Number: B500
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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: +1 952 465 3500
• Email: cs@augsurg.com
• Phone: +1 952 465 3500
• Email: cs@augsurg.com
• Phone: +1 952 465 3500
• Email: cs@augsurg.com
• Phone: +1 952 465 3500
• Email: cs@augsurg.com
• Phone: +1 952 465 3500
• Email: cs@augsurg.com
• Phone: +1 952 465 3500
• Email: cs@augsurg.com
• Phone: +1 952 465 3500
• Email: cs@augsurg.com
• Phone: +1 952 465 3500
• Email: cs@augsurg.com
• Phone: +1 952 465 3500
• Email: cs@augsurg.com
• Phone: +1 952 465 3500
• Email: cs@augsurg.com
• Phone: +1 952 465 3500
• Email: cs@augsurg.com
• Phone: +1 952 465 3500
• Email: cs@augsurg.com
• Phone: +1 952 465 3500
• Email: cs@augsurg.com
• Phone: +1 952 465 3500
• Email: cs@augsurg.com
• Phone: +1 952 465 3500
• Email: cs@augsurg.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855913001992 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112488

FDA Product Code

• DWJ: System, Thermal Regulating

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-18
• Device Publish Date: 2022-10-10

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