Geratherm Colorchoice Oral Digital Thermometer 30010

GUDID 20614801300104

The ColorChoice Oral Digital non-flex tip thermometer is white with blue accent colors around the display window and start button. The temperature measuring range is 90.0°F to 109.0°F. It uses a 1.55V battery with more than 200 hours of continuous use. An audible beep sounds with the peak temperature is reached and the Memory Mode displays the last reading. A battery replacement symbol will appear on the display when the battery is low with an auto shut off feature in 10 minutes. A clear protective case is provided

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

Intermittent electronic patient thermometer Intermittent electronic patient thermometer

• Primary Device ID: 20614801300104
• NIH Device Record Key: 2422ce88-40c4-4c6d-a714-77f557ec433b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Geratherm Colorchoice Oral Digital Thermometer
• Version Model Number: Oral Digital Thermometer with Blue and White color
• Catalog Number: 30010
• 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	00614801300100 [Primary]
GS1	20614801300104 [Package]; Contains: 00614801300100; Package: Bag [25 Units]; In Commercial Distribution

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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