Thermophore Deluxe

GUDID 00040337002650

Standard Thermophore Deluxe II

Battle Creek Equipment Co.

Electric pad localized-body heating system

• Primary Device ID: 00040337002650
• NIH Device Record Key: b5e0c003-6a57-4647-920e-18ed3851885e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermophore Deluxe
• Version Model Number: F00265
• Company DUNS: 001957422
• Company Name: Battle Creek Equipment Co.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00040337002650 [Primary]
GS1	00040337012659 [Package]; Package: Case Pack [12 Units]; In Commercial Distribution

FDA Product Code

• IRT: Pad, Heating, Powered

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: 2020-07-07
• Device Publish Date: 2017-01-04

On-Brand Devices [Thermophore Deluxe]

• 00040337012673: Petite Thermophore Deluxe II
• 00040337012666: Medium Thermophore Deluxe II
• 00040337002650: Standard Thermophore Deluxe II
• 00040337012475: Petite Thermophore Deluxe
• 00040337012468: Medium Thermophore Deluxe
• 00040337012451: Standard Thermophore Deluxe