AccessGUDID - DEVICE: Physiologic Insta-Therm Quick-Scan Thermometer (00057565166702)

GUDID

Device Identifier (DI) Information

Brand Name: Physiologic Insta-Therm Quick-Scan Thermometer
Version or Model: 016-670
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: A.M.G. Médicale Inc

Primary DI Number: 00057565166702
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 207372814 *Terms of Use
Previous DI: 05756516670200

Device Description: This thermometer's innovative design offers 2 convenient and accurate ways to measure body temperature instantly.The Insta-Therm Quick-Scan’s innovative infrared technology allows probe-free scanning from either the ear or forehead. Requires no probe covers! Innovative design allows for choice of 2 body temperature measuring options: Ear and Forehead. Memory stores last 10 readings.

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:	No
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?
17888	Infrared patient thermometer, skin	A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.	Active	false
17887	Infrared patient thermometer, ear	A hand-held, battery-powered, electronic instrument designed to measure the temperature of a patient's ear canal. In most cases it is intended to estimate the internal (core) temperature of the body by measurement of infrared radiation from within the auditory canal. It may claim to measure directly the infrared emissions from the tympanic membrane. An infrared ear thermometer usually displays values corrected by an offset of actual patient oral/rectal temperatures. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: e9fc993d-598e-412f-ab7c-a12c055730e4
Public Version Date: December 04, 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
05756598834224	10	05756598833548	In Commercial Distribution
05756598833548	6	00057565166702	In Commercial Distribution	Box
10057565166709	6	00057565166702	In Commercial Distribution	Inner box
20057565166706	10	10057565166709	In Commercial Distribution	Master case