AccessGUDID - DEVICE: FeverScan Fever Indicators by Physio Logic (00057565168102)

GUDID

Device Identifier (DI) Information

Brand Name: FeverScan Fever Indicators by Physio Logic
Version or Model: 016-800
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 016-800
Company Name: A.M.G. Médicale Inc

Primary DI Number: 00057565168102
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 207372814 *Terms of Use

Device Description: Fever Scan fever indicators are convenient, fast, and effective in monitoring fever. They indicate temperature in 1 degree Celsius increments for up to 48 hours providing peace of mind day and night. Accurate, fast & safe fever monitoring Continuous monitoring for up to 48 hours even when sleeping Display in Celsius and Fahrenheit Hypoallergenic Each pack contains 6 fever indicators

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):	No
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: 5d81e8b9-6e5e-459f-9dc3-e86fa35f4b53
Public Version Date: June 21, 2023
Public Version Number: 1
DI Record Publish Date: June 13, 2023