CSI

GUDID 06946725525784

APK Technology Co.,Ltd.

Tissue saturation oximeter sensor, reprocessed
Primary Device ID06946725525784
NIH Device Record Key25fc62a7-5e22-41a2-a13d-833a79149d1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCSI
Version Model NumberA0309-SA102PU
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
GS106946725525784 [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 Number2
Public Version Date2018-07-06
Device Publish Date2018-04-10

On-Brand Devices [CSI]

06946725525913A0309-SW202PU
06946725525906A0309-SP202PU
06946725525890A0309-SP202PV
06946725525883A0309-SA202PU
06946725525876A0309-SA202PV
06946725525869A0309-SW111PU
06946725525852A0309-SP111PU
06946725525845A0309-SP111PV
06946725525838A0309-SA111PU
06946725525821A0309-SA111PV
06946725525814A0309-SW102PU
06946725525807A0309-SP102PU
06946725525791A0309-SP102PV
06946725525784A0309-SA102PU
06946725525777A0309-SA102PV

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