Cold Therapy Temp-Pads® 50715

GUDID 10613031507157

Water Circulating Hot or Cold Pack

Gentherm Medical, LLC

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• Primary Device ID: 10613031507157
• NIH Device Record Key: 2530a476-619d-4db8-80a4-301d79322dcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cold Therapy Temp-Pads®
• Version Model Number: N/A
• Catalog Number: 50715
• Company DUNS: 004249462
• Company Name: Gentherm Medical, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com

Device Dimensions

• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch
• Weight: 0.34 Pound
• Width: 11 Inch
• Length: 12 Inch

Operating and Storage Conditions

• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10613031507157 [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: 3
• Public Version Date: 2021-09-23
• Device Publish Date: 2016-09-12

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• 10613031501117 - Plastipad® Pediatric Size: 2021-09-23 Water Circulating Hot or Cold Pack