Hot Dog Lower Body Warming Blanket, Pediatric B203

GUDID 00855913001091

Hot Dog Lower Body Warming Blanket, Pediatric B203

AUGUSTINE TEMPERATURE MANAGEMENT LLC

Electric pad whole-body heating system

• Primary Device ID: 00855913001091
• NIH Device Record Key: 88164270-39c1-4300-a98c-71aeaa060b7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hot Dog Lower Body Warming Blanket, Pediatric
• Version Model Number: B203
• Catalog Number: B203
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• 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	00855913001091 [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: 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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