N/A

GUDID 06972040110497

Shenzhen AOJ Medical Technology Co., Ltd

Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin
Primary Device ID06972040110497
NIH Device Record Keyc93be543-9297-4887-be17-46b2cf6e2fc1
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberF103
Company DUNS554409093
Company NameShenzhen AOJ Medical Technology Co., Ltd
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106972040110497 [Primary]
GS106972040110497 [Primary]
GS106972040110497 [Primary]
GS106972040110497 [Primary]
GS106972040110497 [Primary]
GS106972040110497 [Primary]
GS106972040110497 [Primary]
GS106972040110497 [Primary]
GS106972040110497 [Primary]
GS106972040110497 [Primary]
GS106972040110497 [Primary]
GS106972040110497 [Primary]
GS106972040110497 [Primary]
GS106972040110497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
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 Date2020-07-30
Device Publish Date2020-07-22

On-Brand Devices [N/A]

06972040110022AOJ-20A
06972040110268AOJ-20A
06972040110190AOJ-20E-M
06972040110176AOJ-20E
06972040110145AOJ-20A-M
06972040110138AOJ-20B
06972040110121AOJ-20A
06972040110107AOJ-20H
06972040110091AOJ-20F
06972040110046AOJ-20B
06972040110510AOJ-20D
06972040110503AOJ-20C
06972040110497F103
06972040110480F102
06972040110398AOJ-20M
06972040110350AOJ-20C
06972040110343AOJ-20C
06972040110329AOJ-20F
06972040110282AOJ-20D
06972040110220AOJ-20B
06972040110213AOJ-20B
06972040110008AOJ-20E

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