FDA.reportPublic FDA data

myMDI Finger Pulse Oximeter

Primary DI
00842135100053
Brand
myMDI Finger Pulse Oximeter
Company
MEDICAL DEVELOPMENTS INTERNATIONAL LIMITED
Model
PO-FPO-US
Device description
myMDI Finger Pulse Oximeter is a non-invasive device used to measure oxygen saturation and pulse rate via the finger.
Published
2017-04-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
00842135100053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842135100053008421351000538421351000530842135100053

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
751908968
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842135100015Antistatic Compact Space Chamber with Small MaskSP-ANTI-SSUS2017-04-13
00842135100008Antistatic Compact Space ChamberSP-ANTI-SUS2017-04-13
00842135100022Antistatic Compact Space Chamber with Medium MaskSP-ANTI-SMUS2017-04-13
00842135100039Antistatic Compact Space Chamber with Large MaskSP-ANTI-SLUS2017-04-13
00842135100084Antistatic Compact Space Chamber with Antistatic Small MaskSP-ANTI-SSUSMDI2023-08-07
00842135100091Antistatic Compact Space Chamber with Medium Antistatic MaskSP-ANTI-SMUSMDI2023-08-07
00842135100107Antistatic Compact Space Chamber with Large Antistatic MaskSP-ANTI-SLUSMDI2023-08-07
10842135100081Antistatic Compact Space Chamber with Antistatic Small MaskSP-ANTI-SSUSMDI2023-08-07
10842135100098Antistatic Compact Space Chamber with Medium Antistatic MaskSP-ANTI-SMUSMDI2023-08-07
10842135100104Antistatic Compact Space Chamber with Large Antistatic MaskSP-ANTI-SLUSMDI2023-08-07
10842135100012Antistatic Compact Space Chamber with Small MaskSP-ANTI-SSUS2017-04-13
10842135100050myMDI Finger Pulse OximeterPO-FPO-US2017-04-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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