HTP1500 HTP1500

GUDID 10615089310109

Heat Pump Hyperthermia 10in x 7in Dia. Digital Display Mercury Free

ADROIT MEDICAL SYSTEMS, INC.

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• Primary Device ID: 10615089310109
• NIH Device Record Key: 1aad0288-f366-4a58-905b-6b9d739617df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HTP1500
• Version Model Number: HTP1500
• Catalog Number: HTP1500
• Company DUNS: 795104769
• Company Name: ADROIT MEDICAL SYSTEMS, INC.
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10615089310109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970197

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: 5
• Public Version Date: 2023-12-18
• Device Publish Date: 2016-09-23

On-Brand Devices [HTP1500]

• 10615089311106: Accessory Rolling Stand for HTP1500 Pump
• 10615089310109: Heat Pump Hyperthermia 10in x 7in Dia. Digital Display Mercury Free