FDA.report

Safety 1st

Primary DI
00884392575182
Brand
Safety 1st
Company
DOREL JUVENILE GROUP, INC.
Model
TH058
Published
2016-09-01
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

Product Codes

CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications

CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00884392575182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00884392575182008843925751828843925751820884392575182

GMDN Terms

TermDefinition
Infrared patient thermometer, earA hand-held, battery-powered, electronic instrument designed to measure the temperature of a patient's ear canal. In most cases it is intended to estimate the internal (core) temperature of the body by measurement of infrared radiation from within the auditory canal. It may claim to measure directly the infrared emissions from the tympanic membrane. An infrared ear thermometer usually displays values corrected by an offset of actual patient oral/rectal temperatures. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
118841501
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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20884392950495Safety 1stIH5762023-06-15
00884392945411Safety 1stIH5352021-05-30
10884392551954Safety 1stIH1452016-09-01
10884392580534Safety 1stIH2632016-09-01
10884392590793Safety 1stIH3092016-09-01
10884392597525Safety 1stIH3232016-09-01
10884392597532Safety 1stIH3242016-09-01
10884392598065Safety 1stIH3422016-09-01
10884392603127Safety 1stIH3402016-09-01
10884392603493Safety 1stIH3622016-09-01
10884392606623Safety 1stIH3672016-09-01
10884392609211Safety 1stIH3782016-09-01

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