Geratherm Daisy Color Pacifier Digital Thermometer 30070

GUDID 00614801300704

Daisy Infant Pacifier Thermometer is a clinical thermometer intended for the measurement of oral body temperature in infants and young children. The device is waterproof, uses a CR2032 (3 V) battery. Dimensions: 60 mm x 50 mm x 42 mm. Weight: Approx. 23 grams (including battery). Beeper: Approx. 5 secs. sound signal when end temperature reached. Memory: Built-in memory enabling display of the previously measured value. Shut-off: Automatic shut-off in approx. 30 seconds. Backlight Color Coded Visual fever alarm indicators green yellow and red : 36,0 T 37,1 green 37,2 T 37,4 yellow 37,5 T 43,9 red A protective storage cover included

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

Intermittent electronic patient thermometer

• Primary Device ID: 00614801300704
• NIH Device Record Key: 82701603-16e2-4dc4-af48-e3a0c510b09c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Geratherm Daisy Color Pacifier Digital Thermometer
• Version Model Number: RETAIL Baby Pacifier Thermometer
• Catalog Number: 30070
• 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: false
• 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	00614801300704 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981456

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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