FDA.reportPublic FDA data

Famidoc

Primary DI
00854314007121
Brand
Famidoc
Company
FAMIDOC USA, INC.
Model
FDIR-V22
Device description
Non-Contact Infrared Thermometer
Published
2016-12-29
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
K113761000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113761000INFRARED THERMOMETERFamidoc Technology Co., Ltd.2012-09-07FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10854314007128PackageGS140In Commercial Distribution
00854314007121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085431400712810854314007128
00854314007121008543140071218543140071210854314007121

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080370811
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854314007510FamidocFDES1072016-12-29
00854314007527FamidocFDES1082016-12-29
00854314007114FamidocFDIR-V102016-12-29
00854314007503FamidocFDES1052016-12-29
00854314007107FamidocFDIR-V22016-12-29
00854314007305FamidocFDTH-V0-12016-12-29
00854314007312FamidocFDTH-V0-3（frog）2016-12-29
00854314007329FamidocFDTH-V0-3（normal）2016-12-29
00854314007336FamidocFDTH-V0-3（rabbit）2016-12-29
00854314007343FamidocFDTH-V0-42016-12-29
00854314007350FamidocFDTH-V0-122016-12-29
00854314007084FAMIDOCFDCO-V112018-05-10
00854314007008FamidocFDCO-V12016-12-29
00854314007015FamidocFDCO-V22016-12-29

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Primary DI, Brand, Company table
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08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22