AccessGUDID - DEVICE: Non-contact Thermometer without Bluetooth: (04045396219953)

GUDID

Device Identifier (DI) Information

Brand Name: Non-contact Thermometer without Bluetooth:
Version or Model: 1840
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1840
Company Name: Rudolf Riester GmbH

Primary DI Number: 04045396219953
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 537208717 *Terms of Use

Device Description: ri-thermo® sensioPRO / ri-thermo® sensioPRO+ non-contact thermometer is intended for the intermittent measurement and monitoring of human body temperature from the forehead. The device is intended for use of all ages for professional use by one with a good understanding of the operation instruction.

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):	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?
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: 817466c5-1430-4394-a402-4e301907ce03
Public Version Date: February 05, 2021
Public Version Number: 1
DI Record Publish Date: January 28, 2021