BCI

GUDID 06946725525609

APK Technology Co.,Ltd.

Tissue saturation oximeter sensor, reprocessed
Primary Device ID06946725525609
NIH Device Record Key8d555bc9-80d1-4106-8208-f9479e7d8af7
Commercial Distribution StatusIn Commercial Distribution
Brand NameBCI
Version Model NumberA0209-SA130PV
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
GS106946725525609 [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 [BCI]

06946725525647A0209-SW130PU
06946725525630A0209-SP130PU
06946725525623A0209-SP130PV
06946725525616A0209-SA130PU
06946725525609A0209-SA130PV
06946725525593A0209-SW203PU
06946725525586A0209-SP203PU
06946725525579A0209-SP203PV
06946725525562A0209-SA203PU
06946725525555A0209-SA203PV

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