FDA.report

Pro Temp

Primary DI
05060488570599
Brand
Pro Temp
Company
PROACTIVE MEDICAL PRODUCTS, LLC
Model
40010
Catalog number
40010
Device description
Pro Temp Infrared Non-Contact Thermometer
Published
2016-12-13
Public version status
Update
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

Contact Domains

Product Codes

CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications

CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060488570599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060488570599050604885705995060488570599

GMDN Terms

TermDefinition
Infrared patient thermometer, skinA hand-held, battery-powered, electronic 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.

Device Sizes

TypeValueUnit
Height2Inch
Length8Inch
Width3Inch

Sterilization Methods

Method

Contacts

PhoneEmail
+1 855 237 7622sales@proactivemedical.com

Regulatory Flags

DUNS number
078582655
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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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