FDK

GUDID 10859020006151

Speaking Blood Oxygen Fingertip Pulse Oximeter

FUDAKANG INDUSTRIAL LIMITED LIABILITY COMPANY

Pulse oximeter
Primary Device ID10859020006151
NIH Device Record Keye4484ea4-aa21-45cf-a2ae-194880619bfb
Commercial Distribution StatusIn Commercial Distribution
Brand NameFDK
Version Model NumberFT-E688
Company DUNS030152184
Company NameFUDAKANG INDUSTRIAL LIMITED LIABILITY COMPANY
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100859020006154 [Primary]
GS110859020006151 [Package]
Contains: 00859020006154
Package: Inner pack [50 Units]
In Commercial Distribution
GS120859020006158 [Package]
Contains: 00859020006154
Package: Case [100 Units]
In Commercial Distribution

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 Date2021-12-02
Device Publish Date2021-11-24

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10859020006151Speaking Blood Oxygen Fingertip Pulse Oximeter
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