FDA.reportPublic FDA data

Finger pulse oximeter

Primary DI
06944249301891
Brand
Finger pulse oximeter
Company
Shenzhen Kingyield Technology Co., Ltd.
Model
SKU#349771
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944249300016PackageGS124In Commercial Distribution
06944249301891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944249300016069442493000166944249300016
06944249301891069442493018916944249301891

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeterAn electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.

Regulatory Flags#

DUNS number
545348500
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06944249301211Finger pulse oximeterJB72392016-09-15
06944249301907Finger pulse oximeterJB76492016-09-15
06944249302607Finger pulse oximeterDRL76492021-03-08
06944249302621Finger pulse oximeterFSA7649CM2021-03-08
06944249302645Wrist Blood Pressure MonitorFSA8149CM2021-03-08
06944249300238Wrist Blood Pressure MonitorBP01K2016-09-15
06944249300313Upper Arm Blood Pressure MonitorBPM210UL2016-09-15
06944249300320Upper Arm Blood Pressure MonitorUAM-7202016-09-15
06944249300399Wrist Blood Pressure MonitorBPM265W2016-09-15
06944249300870Wrist Blood Pressure MonitorBP5K2016-09-15
06944249300887Wrist Blood Pressure MonitorBPM165W2016-09-15
06944249300924Upper Arm Blood Pressure MonitorBLDP-ARM-02-WL2016-09-15
06944249300931Wrist Blood Pressure MonitorBP220-P202016-09-15
06944249301754Wrist Blood Pressure MonitorJB74232016-09-15
06944249301761Wrist Blood Pressure MonitorJB55382016-09-15
06944249301914Wrist Blood Pressure MonitorJB7423CS2016-09-15
06944249301921Wrist Blood Pressure MonitorCEN7423CS2016-09-15
06944249301938Upper Arm Blood Pressure MonitorBPM210UM2016-09-15
06944249301945Wrist Blood Pressure MonitorJB74232016-09-15
06944249301969Wrist Blood Pressure MonitorBP2112016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
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