Physiologic Fever-Bugz Stick-On Fever Indicators

Basic Information

• Brand Name: Physiologic Fever-Bugz Stick-On Fever Indicators
• Primary DI: 00057565167006
• Version / Model: 016-720US
• 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: 2017-01-05
• Public Version: 5
• Public Version Date: 2020-08-21
• Public Version Status: Update
• Public Device Record Key: 1a321462-d426-4b6a-99fe-a76c50056413

Device Description

Fever-Bugz, the kid friendly fever indicator, allows parents to continue monitoring the child’s temperature up to 48 hours, easily. The encapsulated liquid crystals technology of Fever-Bugz®, provides user’s body temperature in increases of 2 degrees Fahrenheit, visible in seconds. What’s more, Fever-Bugz can be conveniently placed over armpit, forehead or chest. Accurate within 1 degree Fahrenheit.

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPD	Strip, Temperature, Forehead, Liquid Crystal	General Hospital	880.2200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33618	Liquid-crystal patient thermometer, single-use	A device designed to measure a patient's skin, oral, rectal, or axillary (armpit) body temperature. It uses liquid-crystal sensors (usually formed from esters of cholesterol) that are sealed in a plastic band and appear to change colour at indicated temperatures. The device may be used in the home. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05756597263162	GS1	Upper Case	48	In Commercial Distribution
Package	05756597262486	GS1	Inner Box	12	In Commercial Distribution
Primary	00057565167006	GS1
Package	05756597264848	GS1	Lower Case	48	In Commercial Distribution
Package	10057565167003	GS1	Retail box	12	In Commercial Distribution
Package	20057565167000	GS1	Master case	48	In Commercial Distribution
Package	30057565167007	GS1	Skid	30	In Commercial Distribution