Nihon Kohden Disposable

GUDID 06946725526699

APK Technology Co.,Ltd.

Pulse oximeter probe, single-use
Primary Device ID06946725526699
NIH Device Record Key93373634-9f42-4b78-bc53-a8f5df10d9b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameNihon Kohden Disposable
Version Model NumberA1411-SP03
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106946725526699 [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 Date2018-08-06
Device Publish Date2018-07-06

On-Brand Devices [Nihon Kohden Disposable]

06946725526712A1411-SN03
06946725526705A1411-SI03
06946725526699A1411-SP03
06946725526682A1411-SA01C
06946725526675A1411-SA03
06946725525159A1411-SN02
06946725525142A1411-SI02
06946725525135A1411-SP02
06946725525128A1411-SA02
06946725514245A1411-SN01
06946725514238A1411-SI01
06946725514221A1411-SP01
06946725514214A1411-SA01

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