FDA.reportPublic FDA data

AILE fingertip pulse oximeter

Primary DI
06972480913061
Brand
AILE fingertip pulse oximeter
Company
Jiangxi Aicare Medical Technology Co., Ltd.
Model
W011
Device description
The fingertip pulse oximeter is intended to measure the pulse oxygen saturation of arterial hemoglobin and pulse rate. This device is not a medical device and is not intended to diagnose and/or treat any medical condition or disease. This device is for Sports and Aviation use only and not for medical use.
Published
2023-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OCHOximeter, Infrared, Sporting, Aviation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCHOximeter, Infrared, Sporting, AviationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972480913061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972480913061069724809130616972480913061

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554530454
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972480913269COOCEER Electronic SphygmomanometersX82023-08-31
06972480912996AILE Electronic SphygmomanometersX12023-03-04
06972480913009AILE Electronic SphygmomanometersX22023-03-04
06972480913023AILE Electronic SphygmomanometersX62023-03-04
06972480913030AILE Electronic SphygmomanometersX72023-03-04
06972480913047AILE Electronic SphygmomanometersX82023-03-04
06972480913054AILE Electronic SphygmomanometersX112023-03-04
06972480916383AILE Electronic SphygmomanometersX52023-03-04

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