FDA.reportPublic FDA data

SeemtraMed Infrared Ear/Forehead Thermometer

Primary DI
50860001625832
Brand
SeemtraMed Infrared Ear/Forehead Thermometer
Company
SEEMTRAMED LLC
Model
PG-IRT1603
Device description
Infrared ear/forehead thermometer
Published
2019-06-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182597000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182597000Infrared thermometerShenzhen Pango Electronic Co., Ltd.2019-04-03FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50860001625832PackageGS160In Commercial Distribution
00860001625837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5086000162583250860001625832
00860001625837008600016258378600016258370860001625837

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, ear/skinA hand-held, battery-powered, electronic instrument designed to measure: 1) the temperature of a patient's ear canal, typically to estimate the internal (core) temperature; and 2) the temperature of a site on the skin (e.g., axilla, forehead), by measurement of body infrared emissions. It typically includes both a skin-surface tip and an intra-aural tip. This device is intended for use in the home or healthcare facility. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
917-720-2575seemtramed@gmail.com

Regulatory Flags#

DUNS number
117025040
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860001625813SeemtraMed Infrared ThermometerEF 100A2019-05-09
00860001625806SeemtraMed Blood Pressure MonitorSBPM-1585-S2019-04-25
00860001625837SeemtraMed Infrared Ear/Forehead ThermometerPG-IRT16032019-06-10

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