AccessGUDID - DEVICE: ProScan Non-Contact Infrared Thermometer by Physio Logic (00057565166603)

GUDID

Device Identifier (DI) Information

Brand Name: ProScan Non-Contact Infrared Thermometer by Physio Logic
Version or Model: 016-660
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: A.M.G. Médicale Inc

Primary DI Number: 00057565166603
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 207372814 *Terms of Use

Device Description: 3 in 1 Thermometer: Body, Room, Liquids and surfaces Non-contact infrared probe Professional Accuracy Faster and more precise than an ear thermometer Non-Contact up to 1- 2" (3 cm - 5 cm) distance from forehead. This means a greatly reduced risk of contagion, without the need for probe covers. Back-lit screen with colour-coded fever alert: green for normal, orange for a low fever and red for a fever of or above 38 C (100.4 F). Fully programmable alerts can be set to detect fever for a specific age group or illness. Use it to ensure that food temperature is safe before serving. Prevent scalding due to hot bath water. Audio alert signals peak temperature and fever. Voice feature can assist users with impaired vision and can be set to English, French, Spanish or mute. Keeps the last 32 temperature readings in memory. Displays in C or F. Auto shut-off for extended battery life. Longevity: 40,000 readings. 2 alkaline AA batteries included.

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

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: 47f890f7-845e-42b7-ad6f-7808fd64566c
Public Version Date: December 04, 2020
Public Version Number: 5
DI Record Publish Date: March 04, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00057565942641	1	00057565166603	2020-03-11	Not in Commercial Distribution	Retail
00057565999126	6	00057565942641	2020-03-11	Not in Commercial Distribution	Case
05756594264148	1	00057565166603		In Commercial Distribution	Retail box
05756599912648	6	05756594264148		In Commercial Distribution	Master case
10057565942648	1	00057565166603		In Commercial Distribution	Retail Box
20057565999120	6	10057565942648		In Commercial Distribution	Master Case
10057565166600	6	00057565166603		In Commercial Distribution	Master case