AccessGUDID - DEVICE: Pulse Oximeter (D040200121501)

GUDID

Device Identifier (DI) Information

Brand Name: Pulse Oximeter
Version or Model: 20012150
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: WHIP-MIX CORPORATION

Primary DI Number: D040200121501
Issuing Agency: HIBCC
Commercial Distribution End Date: September 29, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 006385173 *Terms of Use

Device Description: The GEM is an easy to use Pulse Oximeter that utilizes cloud technology for convenient and prompt readings. The GEM is designed to assess the functioning of the airway using SPO2 and variations in heart rate to measure how well the airway is functioning. The Oximeter measures the blood oxygen level and heart rate then transmits the data to the Galaxy Tablet for storage and processing

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
37808	Pulse oximeter probe, reusable	A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. This is a reusable device.	Active	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 41b61d79-27ff-4f09-8efb-b4401d3d4af2
Public Version Date: September 30, 2022
Public Version Number: 5
DI Record Publish Date: May 01, 2017