AccessGUDID - DEVICE: WowGoHealth Pulse Oximeter GSH601 (04719878124027)

GUDID

Device Identifier (DI) Information

Brand Name: WowGoHealth Pulse Oximeter GSH601
Version or Model: GSH601
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Orange
Company Name: GOLDEN SMART HOME TECHNOLOGY CORP.

Primary DI Number: 04719878124027
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 656002163 *Terms of Use

Device Description: The pulse oximeter is a reusable device, and it’s intended for intermittent checks of oxygen saturation and pulse rate for adults in a home-use only. This device is not intended for continuous monitoring. The device is intended to use of Over-The-Counter.

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):	No
Over the Counter (OTC):	Yes
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?
45607	Pulse oximeter	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OCH	Oximeter, Infrared, Sporting, Aviation

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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 Atmospheric Pressure: between 86 and 106 KiloPascal
Handling Environment Humidity: between 15 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 50 Gram
Height: 58 Millimeter
Width: 34 Millimeter
Depth: 30 Millimeter

Device Record Status

Public Device Record Key: d76d7313-e573-4cee-a155-ae54c1229561
Public Version Date: November 10, 2021
Public Version Number: 2
DI Record Publish Date: January 26, 2021