myMDI Finger Pulse Oximeter

GUDID 10842135100050

myMDI Finger Pulse Oximeter is a non-invasive device used to measure oxygen saturation and pulse rate via the finger.

MEDICAL DEVELOPMENTS INTERNATIONAL LIMITED

Pulse oximeter, line-powered
Primary Device ID10842135100050
NIH Device Record Keya3b5705e-ad52-4667-a173-0280479f94de
Commercial Distribution StatusIn Commercial Distribution
Brand NamemyMDI Finger Pulse Oximeter
Version Model NumberPO-FPO-US
Company DUNS751908968
Company NameMEDICAL DEVELOPMENTS INTERNATIONAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100842135100053 [Primary]
GS110842135100050 [Package]
Contains: 00842135100053
Package: Outer Carton [250 Units]
In Commercial Distribution

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-04-13

Devices Manufactured by MEDICAL DEVELOPMENTS INTERNATIONAL LIMITED

00842135100015 - Antistatic Compact Space Chamber with Small Mask2023-09-25
10842135100081 - Antistatic Compact Space Chamber with Antistatic Small Mask2023-08-15 An Anti-Static Compact Space Chamber with a Small Antistatic Face Mask
10842135100098 - Antistatic Compact Space Chamber with Medium Antistatic Mask2023-08-15 Antistatic Compact Space Chamber with Medium Antistatic Mask
10842135100104 - Antistatic Compact Space Chamber with Large Antistatic Mask2023-08-15 Antistatic Compact Space Chamber with Large Antistatic Mask
00842135100008 - Antistatic Compact Space Chamber2018-07-06 An Anti-Static Compact Space Chamber
10842135100012 - Antistatic Compact Space Chamber with Small Mask2018-07-06
00842135100022 - Antistatic Compact Space Chamber with Medium Mask2018-07-06 An Anti-Static Compact Space Chamber with a Medium Silicone Face Mask.
00842135100039 - Antistatic Compact Space Chamber with Large Mask2018-07-06 An Anti-Static Compact Space Chamber with a Large Silicone Face Mask

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