AccessGUDID - DEVICE: myMDI Finger Pulse Oximeter (00842135100053)

GUDID

Device Identifier (DI) Information

Brand Name: myMDI Finger Pulse Oximeter
Version or Model: PO-FPO-US
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDICAL DEVELOPMENTS INTERNATIONAL LIMITED

Primary DI Number: 00842135100053
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 751908968 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17148	Pulse oximeter, line-powered	A mains electricity (AC-powered) photoelectric device intended for the continuous transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically used bedside.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DQA	Oximeter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit
Handling Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 50 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a3b5705e-ad52-4667-a173-0280479f94de
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: April 13, 2017