Geratherm Baby ColorChoice Digital Thermometer 30060

GUDID 00614801300605

Digital thermometer with backlight, 10 second readings, beeps when ready, flextip, jumbo display, waterproof, auto shut-off, dual scale provided with protective case.

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

Intermittent electronic patient thermometer Intermittent electronic patient thermometer

• Primary Device ID: 00614801300605
• NIH Device Record Key: 7f3103cd-26e8-441f-a573-d06a3930c720
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Geratherm Baby ColorChoice Digital Thermometer
• Version Model Number: Retail Pink Digital Thermometer w-backlight
• Catalog Number: 30060
• 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	00614801300605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070028

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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