Medke

GUDID 06971018115267

Shenzhen MedKe Technology Co., Ltd

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Primary Device ID06971018115267
NIH Device Record Key3513e9de-2afa-40cf-8f48-a77df446d43f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedke
Version Model NumberP1419-01
Company DUNS529655709
Company NameShenzhen MedKe Technology Co., Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106971018115267 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-19
Device Publish Date2019-12-11

On-Brand Devices [Medke]

06971018115496P9119
06971018115212P8119
06971018114949P4110C
06971018115229P1019-01
06971018115465P12419-01
06971018115458P12319-01
06971018115441P12219-01
06971018115434P12119-01
06971018115427P12019-01
06971018115410P11919-01
06971018115403P11819-01
06971018115397P11719-01
06971018115380P11619-01
06971018115373P11519-01
06971018115366P11419-01
06971018115359P11319-01
06971018115342P11219-01
06971018115335P11119-01
06971018115328P11019-01
06971018115311P1919-01
06971018115304P1819-01
06971018115298P1719-01
06971018115281P1619-01
06971018115274P1519-01
06971018115267P1419-01
06971018115250P1319-01
06971018115243P1219-01
06971018115236P1119-01
06971018118060P9318E
06971018118046P8119A
06971018117698P1719-01
06971018111030P9119A
06971018110613P1019-01
00192243000104P1319D-01
00192243000098P1315F-01BC

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