Gebauer's Ethyl Chloride Mist Spray 0386-0001-02

GUDID 00303860001027

EC Mist Topical Anesthetic Spray

GEBAUER COMPANY

Cold/cool therapy spray

• Primary Device ID: 00303860001027
• NIH Device Record Key: 2854fbfa-a297-4132-94da-160330111d8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gebauer's Ethyl Chloride Mist Spray
• Version Model Number: 0386-0001-02
• Catalog Number: 0386-0001-02
• Company DUNS: 004166021
• Company Name: GEBAUER COMPANY
• 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: true
• Serial Number: false
• 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: 800-321-9348
• Email: information@gebauer.com

Device Dimensions

• Total Volume: 116 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00303860001027 [Primary]
GS1	10303860001024 [Package]; Package: [4 Units]; In Commercial Distribution
GS1	20303860001021 [Package]; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190161

FDA Product Code

• MLY: Refrigerant, Topical (Vapocoolant)

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: 2020-03-06
• Device Publish Date: 2020-02-27