ThermaZone 003-19

GUDID 00854682001158

ThermaZone Ankle Relief Pad

INNOVATIVE MEDICAL EQUIPMENT, LLC

Circulating-fluid thermal therapy system pack, reusable Circulating-fluid localized thermal therapy system pack, reusable Circulating-fluid localized thermal therapy system pack, reusable Circulating-fluid localized thermal therapy system pack, reusable Circulating-fluid localized thermal therapy system pack, reusable Circulating-fluid localized thermal therapy system pack, reusable Circulating-fluid localized thermal therapy system pack, reusable Circulating-fluid localized thermal therapy system pack, reusable Circulating-fluid localized thermal therapy system pack, reusable Circulating-fluid localized thermal therapy system pack, reusable Circulating-fluid localized thermal therapy system pack, reusable Circulating-fluid localized thermal therapy system pack, reusable Circulating-fluid localized thermal therapy system pack, reusable Circulating-fluid localized thermal therapy system pack, reusable Circulating-fluid localized thermal therapy system pack, reusable Circulating-fluid localized thermal therapy system pack, reusable Circulating-fluid localized thermal therapy system pack, reusable

• Primary Device ID: 00854682001158
• NIH Device Record Key: 25e83115-c725-4574-8afa-41c8654ccce7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermaZone
• Version Model Number: 003-19
• Catalog Number: 003-19
• Company DUNS: 833969186
• Company Name: INNOVATIVE MEDICAL EQUIPMENT, LLC
• 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: false
• 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: 8779019663
• Email: info@therma-zone.com
• Phone: 8779019663
• Email: info@therma-zone.com
• Phone: 8779019663
• Email: info@therma-zone.com
• Phone: 8779019663
• Email: info@therma-zone.com
• Phone: 8779019663
• Email: info@therma-zone.com
• Phone: 8779019663
• Email: info@therma-zone.com
• Phone: 8779019663
• Email: info@therma-zone.com
• Phone: 8779019663
• Email: info@therma-zone.com
• Phone: 8779019663
• Email: info@therma-zone.com
• Phone: 8779019663
• Email: info@therma-zone.com
• Phone: 8779019663
• Email: info@therma-zone.com
• Phone: 8779019663
• Email: info@therma-zone.com
• Phone: 8779019663
• Email: info@therma-zone.com
• Phone: 8779019663
• Email: info@therma-zone.com
• Phone: 8779019663
• Email: info@therma-zone.com
• Phone: 8779019663
• Email: info@therma-zone.com
• Phone: 8779019663
• Email: info@therma-zone.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854682001158 [Primary]

FDA Product Code

• ILO: Pack, Hot Or Cold, Water Circulating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [ThermaZone]

• 00854682001943: ThermaZone Single Patient Use Shoulder Pad.
• 00854682001929: ThermaZone Medical Grade Power Supply Assembly.
• 00854682001615: ThermaZone Thermal Therapy Device with medical grade power supply.
• 00854682001578: ThermaZone Thermal Therapy Device with standard power supply
• 00854682001561: ThermaZone Standard Power Supply Assembly.
• 00854682001554: ThermaZone IV Pole with basket (Ships in three cartons).
• 00854682001547: ThermaZone Hospital Bed Bracket. This device can attach directly to the patient's bed or to the
• 00854682001523: ThermaZone Single Patient Use Hip Pad.
• 00854682001509: ThermaZone Single Patient Use Ankle Pad.
• 00854682001493: ThermaZone Single Patient Use Back Pad.
• 00854682001486: ThermaZone Single Patient Use Knee Pad.
• 00854682001349: ThermaZone Universal Relief Pad
• 00854682001301: ThermaZone Occipital Rear Head Relief Pad
• 00854682001172: ThermaZone Blue Tubing Assembly
• 00854682001158: ThermaZone Ankle Relief Pad
• 00854682001141: ThermaZone Back Relief Pad
• 00854682001134: ThermaZone Knee Relief Pad
• 00854682001127: ThermaZone Large Shoulder Relief Pad
• 00854682001110: ThermaZone Shoulder Relief Pad
• 00854682001042: ThermaZone Front & Side Head Relief Pad
• 00854682001028: ThermaZone Eye Relief Pad.
• 00854682001950: ThermaZone Range of Motion (ROM) Knee Brace with Advanced Heating / Cooling Therapy
• 00854682001356: ThermaZone Thermal Therapy Device with medical grade power supply