Nellcor Disposable

GUDID 06946725524176

APK Technology Co.,Ltd.

Tissue saturation oximeter sensor, single-use
Primary Device ID06946725524176
NIH Device Record Key9be06782-d94d-4841-b664-944e39825184
Commercial Distribution StatusIn Commercial Distribution
Brand NameNellcor Disposable
Version Model NumberA1418-SA01
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
GS106946725524176 [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 [Nellcor Disposable]

06946725524183A1418-SP01
06946725524176A1418-SA01

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