Geratherm SolarTherm Speed Digital Thermometer 40053

GUDID 00614801400534

SolarTherm Speed digital flex tip thermometer is white with blue accent colors and is used to measure body temperatures orally, rectally or axillary. The temperature measuring range is from 89.6°~111.0°F. If the reading is below 89.6°F, the letter L will be displayed indicating Low reading. If the reading is above 111.0°F, the letter H will be displayed indicating High reading. Energy is supplied using an integrated solar cell with approximately 25 temperature readings within 60-minutes before a recharge is needed. There is an audible beeping for 8 seconds after peak temperature is reached, built-in memory recall enabling display of the previously measured and automatic shut-off in about 9 minutes. Prior to using the solar cell must be exposed to a light source at least 3 hours. This may be in room light or sunlight. A half circle symbol will appear in the display when the solar cell needs to be recharged. Turn the power off before recharging, the solar cell should face the light source during recharging and for ongoing use store on counter top where thermometer is exposed to light throughout the day. A clear plastic cover is provided.

R.G. ENTERPRISES (U.S.A.), INC.

Intermittent electronic patient thermometer

• Primary Device ID: 00614801400534
• NIH Device Record Key: 590edd0b-b422-4985-b9cb-e31f5baee8af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Geratherm SolarTherm Speed Digital Thermometer
• Version Model Number: Retail SolarTherm Digital Thermomete
• Catalog Number: 40053
• Company DUNS: 928998905
• Company Name: R.G. ENTERPRISES (U.S.A.), 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: true
• 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: 248-504-6726
• Email: MaryRN@rgmd.com
• Phone: 248-504-6726
• Email: MaryRN@rgmd.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614801400534 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K903590

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

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: 2018-07-06
• Device Publish Date: 2016-09-01

Devices Manufactured by R.G. ENTERPRISES (U.S.A.), INC.

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