HP

GUDID 06946725520444

APK Technology Co.,Ltd.

Tissue saturation oximeter sensor, reprocessed
Primary Device ID06946725520444
NIH Device Record Keydebd2f08-27cd-4ede-bf57-5d16659ff7fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameHP
Version Model NumberA0816-SP105PV
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
GS106946725520444 [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 [HP]

06946725520529A0816-SW106PU
06946725520512A0816-SP106PU
06946725520505A0816-SP106PV
06946725520499A0816-SA106PU
06946725520482A0816-SA106PV
06946725520468A0816-SW105PU
06946725520451A0816-SP105PU
06946725520444A0816-SP105PV
06946725520437A0816-SA105PU
06946725520420A0816-SA105PV

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