FDA.report

Non-contact Thermometer without Bluetooth:

Primary DI
04045396219953
Brand
Non-contact Thermometer without Bluetooth:
Company
Rudolf Riester GmbH
Model
1840
Catalog number
1840
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.
Published
2021-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications

CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04045396219953PrimaryGS10

GMDN Terms

TermDefinition
Infrared patient thermometer, skinA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
537208717
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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