Clever Choice 98302-0001-91

GUDID 10898302001910

Clever Choice Comfort Heat + (plus)

SIMPLE DIAGNOSTICS INC

Electric pad localized-body heating system

• Primary Device ID: 10898302001910
• NIH Device Record Key: 430d69b8-724b-4409-a800-5c4fc91d48ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clever Choice
• Version Model Number: Comfort Heat+ SDI-HPK
• Catalog Number: 98302-0001-91
• Company DUNS: 004135503
• Company Name: SIMPLE DIAGNOSTICS INC
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 877-342-2385
• Email: customerservice@simplediagnost
• Phone: 877-342-2385
• Email: customerservice@simplediagnostics.com
• Phone: 877-342-2385
• Email: customerservice@simplediagnostics.com
• Phone: 877-342-2385
• Email: customerservice@simplediagnostics.com
• Phone: 877-342-2385
• Email: customerservice@simplediagnostics.com
• Phone: 877-342-2385
• Email: customerservice@simplediagnostics.com
• Phone: 877-342-2385
• Email: customerservice@simplediagnostics.com
• Phone: 877-342-2385
• Email: customerservice@simplediagnostics.com
• Phone: 877-342-2385
• Email: customerservice@simplediagnostics.com
• Phone: 877-342-2385
• Email: customerservice@simplediagnostics.com
• Phone: 877-342-2385
• Email: customerservice@simplediagnostics.com
• Phone: 877-342-2385
• Email: customerservice@simplediagnostics.com
• Phone: 877-342-2385
• Email: customerservice@simplediagnostics.com

Device Dimensions

• Length: 24 Inch
• Length: 24 Inch
• Width: 12 Inch
• Length: 24 Inch
• Width: 12 Inch
• Length: 24 Inch
• Width: 12 Inch
• Length: 24 Inch
• Width: 12 Inch
• Length: 24 Inch
• Width: 12 Inch
• Length: 24 Inch
• Width: 12 Inch
• Length: 24 Inch
• Width: 12 Inch
• Length: 24 Inch
• Width: 12 Inch
• Length: 24 Inch
• Width: 12 Inch
• Length: 24 Inch
• Width: 12 Inch
• Length: 24 Inch
• Width: 12 Inch
• Length: 24 Inch
• Width: 12 Inch
• Length: 24 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00898302001913 [Primary]
GS1	10898302001910 [Package]; Contains: 00898302001913; Package: Case [6 Units]; In Commercial Distribution

FDA Product Code

• IRT: Pad, Heating, Powered

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: 2019-04-02
• Device Publish Date: 2019-03-25

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• 10898302140190: Clever Choice Disposable Face Masks - Medical
• 10898302001453: Clever Choice Whisper Aire Pediatric Child Nebulizer with mask and tubing
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• 00898302140698: Replacement Cuff for Automatic Blood Pressure Monitors. Arm testing site.