FDK

GUDID 10859020006434

FDK DIGITAL THERMOMETER

FUDAKANG INDUSTRIAL LIMITED LIABILITY COMPANY

General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use
Primary Device ID10859020006434
NIH Device Record Keyef590703-7785-4a37-9e0b-9133ab60da76
Commercial Distribution StatusIn Commercial Distribution
Brand NameFDK
Version Model NumberBT-A13
Company DUNS030152184
Company NameFUDAKANG INDUSTRIAL LIMITED LIABILITY COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100859020006437 [Primary]
GS100859020006437 [Primary]
GS100859020006437 [Primary]
GS100859020006437 [Primary]
GS110859020006434 [Package]
Contains: 00859020006437
Package: Inner pack [30 Units]
In Commercial Distribution
GS110859020006434 [Package]
Contains: 00859020006437
Package: Inner pack [30 Units]
In Commercial Distribution
GS110859020006434 [Package]
Contains: 00859020006437
Package: Inner pack [30 Units]
In Commercial Distribution
GS110859020006434 [Package]
Contains: 00859020006437
Package: Inner pack [30 Units]
In Commercial Distribution
GS120859020006431 [Package]
Contains: 00859020006437
Package: Case [360 Units]
In Commercial Distribution
GS120859020006431 [Package]
Contains: 00859020006437
Package: Case [360 Units]
In Commercial Distribution
GS120859020006431 [Package]
Contains: 00859020006437
Package: Case [360 Units]
In Commercial Distribution
GS120859020006431 [Package]
Contains: 00859020006437
Package: Case [360 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [FDK]

00867464000294FDK ARM CUFF BP MONITOR
00867464000287FDK ARM CUFF BP MONITOR
00867464000270FDK ARM CUFF BP MONITOR
00867464000263FDK ARM CUFF BP MONITOR
00867464000256FDK ARM CUFF BP MONITOR
00867464000249FDK WRIST CUFF BP MONITOR
00867464000232FDK WRIST CUFF BP MONITOR
00867464000225FDK WRIST CUFF BP MONITOR
00867464000218FDK WRIST CUFF BP MONITOR
00867464000201FDK WRIST CUFF BP MONITOR
00859020006260FDK ARM CUFF BP MONITOR
00859020006246FDK ARM CUFF BP MONITOR
00859020006208FDK Non-Contact Infrared Thermometer
00859020006130FDK WRIST CUFF BP MONITOR
00859020006116FDK ARM CUFF BP MONITOR
00859020006079FDK NON-CONTACT INFRARED THERMOMETER
20859020006066FDK NON-CONTACT INFRARED THERMOMETER
00859020006055FDK FOREHEAD & EAR INFRARED THERMOMETER
00859020006048FDK EAR TYPE INFRARED THERMOMETER
00859020006031FDK DIGITAL THERMOMETER
00859020006024FDK DIGITAL THERMOMETER
00859020006017FDK DIGITAL THERMOMETER
00859020006000FDK ARM CUFF BP MONITOR
00859020006321FDK ARM CUFF BP MONITOR
00859020006178FDK DIGITAL THERMOMETER
00859020006444FDK NON-CONTACT INFRARED THERMOMETER
10859020006434FDK DIGITAL THERMOMETER

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