FDA.reportPublic FDA data

OctiveTech

Primary DI
00897429002056
Brand
OctiveTech
Company
Clinical Guard
Model
FDIR-V1
Published
2016-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K052849000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052849000INFRARED THERMOMETER, FDIR-V1Famidoc Technology Co., Ltd.2005-10-26FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10897429002053PackageGS160In Commercial Distribution
00897429002056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089742900205310897429002053
00897429002056008974290020568974290020560897429002056

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
827033924
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00897429002230Clinical GuardCMS50E2017-12-06
00897429002469Clinical GuardCMS500S2017-03-30
00897429002520Clinical GuardCMS 50DL2017-06-08
00897429002971Clinical GuardCMS50F2017-12-06
10897429002237Clinical GuardCMS50E2017-12-06
20897429002463Clinical GuardCMS500S2017-03-30
00897429002476Clinical GuardAero22017-08-02
20897429002524Clinical GuardCMS 50DL2017-06-08
10897429002978Clinical GuardCMS50F2017-12-06
20851950008165Virginia National Guard50DL-BContec2018-01-15
00851950008130ArvolifeHCG Midstream2018-03-27

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Primary DI, Brand, Company table
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