Hot Dog Pediatric Head Warming Wrap, Large B271

GUDID 00855913001916

Labeled: Hot Dog Pediatric Head Warming Wrap, Large B271

AUGUSTINE TEMPERATURE MANAGEMENT LLC

Electric pad whole-body heating system

• Primary Device ID: 00855913001916
• NIH Device Record Key: a30952fb-c6cf-41f3-af1b-8a90cfaa23f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hot Dog Pediatric Head Warming Wrap, Large
• Version Model Number: B271
• Catalog Number: B271
• 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: true
• 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	00855913001916 [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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