Geratherm Colorchoice Rectal Digital Thermometer

Basic Information

• Brand Name: Geratherm Colorchoice Rectal Digital Thermometer
• Primary DI: 00614801300513
• Version / Model: Rectal Digital Thermometer with red and white colors
• Catalog Number: 30051
• Company Name: R.G. ENTERPRISES (U.S.A.), INC.
• Labeler DUNS: 928998905
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 68838a3e-2ca3-4fcc-946b-3f6c48c67149

Device Description

The ColorChoice Rectal Digital non-flex tip thermometer is white with red 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
14035	Intermittent electronic patient thermometer	A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00614801300513	GS1
Package	20614801300517	GS1	BAG	25	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K903590	000