Hot Dog Patient Warming System Controller WC01 WC01

GUDID 00855913001107

Labeled: Hot Dog WC01 Patient Warming System Controller

AUGUSTINE TEMPERATURE MANAGEMENT LLC

Electric pad whole-body heating system

• Primary Device ID: 00855913001107
• NIH Device Record Key: e5784971-0bf6-44ae-8a85-bf5755ac89f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hot Dog Patient Warming System Controller WC01
• Version Model Number: WC01
• Catalog Number: WC01
• 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: false
• 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	00855913001107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052392

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

Devices Manufactured by AUGUSTINE TEMPERATURE MANAGEMENT LLC

• 00850011479711 - WaffleGrip: 2024-09-20 WaffleGrip Trendelenburg Positioning Kit for Electrosurgery, 10 Pack
• 00855913001848 - HotDog Underbody Warming Mattress + Return Electrode, 89 cm (35"): 2024-09-20 The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controllin
• 00855913001817 - HotDog Underbody Warming Mattress + Return Electrode, 82 cm (32"): 2023-07-25 The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controllin
• 00855913001824 - HotDog Underbody Warming Mattress + Return Electrode, 127 cm (50"): 2023-07-25 The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controllin
• 00850011479100 - WaffleGrip Trendelenburg Positioning Kit + BackSaver Slide Sheet: 2022-10-18 WaffleGrip Trendelenburg Positioning Kit + Backsaver Slide Sheet, 10 Pack
• 00850011479506 - WaffleGrip Trendelenburg Positioning Kit for Warming Pad, 10 Pack: 2022-10-18 WaffleGrip Trendelenburg Positioning Kit + BackSaver Slide Sheet for Warming Pad, 10 Pack
• 00850011479575 - WaffleGrip: 2022-10-18 WaffleGrip Disposables for Warming Pad
• 00850011479636 - WaffleGrip: 2022-10-18 WaffleGrip Bracket Set