Physio Logic Accuflex Digital Thermometer

Basic Information

• Brand Name: Physio Logic Accuflex Digital Thermometer
• Primary DI: 00057565166283
• Version / Model: 016-628
• Catalog Number: 016-628
• 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: 2023-06-09
• Public Version: 2
• Public Version Date: 2025-12-15
• Public Version Status: Update
• Public Device Record Key: daeeb53a-9ac9-48e4-8dad-afb19f8cde46

Device Description

Accuflex® single-patient digital thermometers can help to prevent the risk of cross-contamination, nosocomial infections and make it easy to prevent the spread of contamination among patients. This digital thermometer is easy to use and provides fast readings. Most importantly, Accuflex is reliable and accurate for patients of all ages. Accurate within ± 0.1°C in the 35°C to 42°C range Fast response time: 10 seconds Washable for easy cleaning Gentle-flex tip for patient comfort Auto shut-off feature Memory recall / display of last 30 readings Individually packaged, includes storage case Anti-Bacterial additive Convenient colour codes – blue for oral and red for rectal

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
Package	00057565972846	GS1		12	In Commercial Distribution
Primary	00057565166283	GS1
Package	00057565972754	GS1	Master Case	12	In Commercial Distribution