Physio Logic Digiflex 10 Thermometer

Basic Information

• Brand Name: Physio Logic Digiflex 10 Thermometer
• Primary DI: 00057565166450
• Version / Model: 016-645
• Catalog Number: 016-645
• Company Name: A.M.G. Médicale Inc
• Labeler DUNS: 207372814
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-16
• Public Version: 3
• Public Version Date: 2020-08-21
• Public Version Status: Update
• Public Device Record Key: c6559d1b-12aa-4ee9-910a-5d9223cddac7

Device Description

Accurate readings in as little as 10 seconds. •Accurate within 0.2 °F / 0.1 °C •Use orally, rectally or underarm •Gentle-flex tip for added comfort & safety. •Fast 10 second reading* •Beep signals peak temperature •Water resistant for easy cleaning •Automatic shut-off feature •Includes storage case

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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
Package	05756599953924	GS1	Case	24	In Commercial Distribution
Package	05756599952248	GS1	Box	12	In Commercial Distribution
Primary	00057565166450	GS1
Package	10057565166457	GS1	Inner box	12	In Commercial Distribution
Package	20057565166454	GS1	Master case	24	In Commercial Distribution
Previous	05756516645000	GS1