AccessGUDID - DEVICE: Physiologic Fever-Bugz Stick-On Fever Indicators (00057565167006)

GUDID

Device Identifier (DI) Information

Brand Name: Physiologic Fever-Bugz Stick-On Fever Indicators
Version or Model: 016-720US
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: A.M.G. Médicale Inc

Primary DI Number: 00057565167006
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 207372814 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPD	Strip, Temperature, Forehead, Liquid Crystal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1a321462-d426-4b6a-99fe-a76c50056413
Public Version Date: August 21, 2020
Public Version Number: 5
DI Record Publish Date: January 05, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
05756597263162	48	05756597262486	In Commercial Distribution	Upper Case
05756597262486	12	00057565167006	In Commercial Distribution	Inner Box
05756597264848	48	05756597262486	In Commercial Distribution	Lower Case
10057565167003	12	00057565167006	In Commercial Distribution	Retail box
20057565167000	48	10057565167003	In Commercial Distribution	Master case
30057565167007	30	20057565167000	In Commercial Distribution	Skid