GE-Marquette

GUDID 06946725520970

APK Technology Co.,Ltd.

Tissue saturation oximeter sensor, reprocessed
Primary Device ID06946725520970
NIH Device Record Keye67cd8ec-666c-4181-bf67-882a1cd4cdc8
Commercial Distribution StatusIn Commercial Distribution
Brand NameGE-Marquette
Version Model NumberA0705-SA104PU
Company DUNS529691989
Company NameAPK 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 Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106946725520970 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-03-06

On-Brand Devices [GE-Marquette]

06946725521007A0705-SW104PU
06946725520994A0705-SP104PU
06946725520987A0705-SP104PV
06946725520970A0705-SA104PU
06946725520963A0705-SA104PV

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