Gebauer's Instant Ice 0386-0010-01

GUDID 20303860010016

II Med Topical Skin Refrigerant

GEBAUER COMPANY

Cold/cool therapy spray Cold/cool therapy spray Cold/cool therapy spray Cold/cool therapy spray Cold/cool therapy spray Cold/cool therapy spray Cold/cool therapy spray Cold/cool therapy spray Cold/cool therapy spray Cold/cool therapy spray Cold/cool therapy spray Cold/cool therapy spray Cold/cool therapy spray Cold/cool therapy spray Cold/cool therapy spray Cold/cool therapy spray Cold/cool therapy spray Cold/cool therapy spray

• Primary Device ID: 20303860010016
• NIH Device Record Key: aae0f02e-0b27-4eb2-9233-9db7700351b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gebauer's Instant Ice
• Version Model Number: 0386-0010-01
• Catalog Number: 0386-0010-01
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 800-321-9348
• Email: information@gebauer.com
• Phone: 800-321-9348
• Email: information@gebauer.com
• Phone: 800-321-9348
• Email: information@gebauer.com
• Phone: 800-321-9348
• Email: information@gebauer.com
• Phone: 800-321-9348
• Email: information@gebauer.com
• Phone: 800-321-9348
• Email: information@gebauer.com
• Phone: 800-321-9348
• Email: information@gebauer.com
• Phone: 800-321-9348
• Email: information@gebauer.com
• Phone: 800-321-9348
• Email: information@gebauer.com
• Phone: 800-321-9348
• Email: information@gebauer.com
• Phone: 800-321-9348
• Email: information@gebauer.com
• Phone: 800-321-9348
• Email: information@gebauer.com
• Phone: 800-321-9348
• Email: information@gebauer.com
• Phone: 800-321-9348
• Email: information@gebauer.com
• Phone: 800-321-9348
• Email: information@gebauer.com
• Phone: 800-321-9348
• Email: information@gebauer.com
• Phone: 800-321-9348
• Email: information@gebauer.com
• Phone: 800-321-9348
• Email: information@gebauer.com

Device Dimensions

• Total Volume: 103.5 Milliliter
• Total Volume: 116 Milliliter
• Total Volume: 116 Milliliter
• Total Volume: 116 Milliliter
• Total Volume: 116 Milliliter
• Total Volume: 116 Milliliter
• Total Volume: 116 Milliliter
• Total Volume: 116 Milliliter
• Total Volume: 116 Milliliter
• Total Volume: 116 Milliliter
• Total Volume: 116 Milliliter
• Total Volume: 116 Milliliter
• Total Volume: 116 Milliliter
• Total Volume: 116 Milliliter
• Total Volume: 116 Milliliter
• Total Volume: 116 Milliliter
• Total Volume: 116 Milliliter
• Total Volume: 116 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00303860010012 [Primary]
GS1	20303860010016 [Package]; Contains: 00303860010012; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021726

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