AccessGUDID - DEVICE: WowGoHealth Blood Pressure Monitor GSH885B (04719878120029)

GUDID

Device Identifier (DI) Information

Brand Name: WowGoHealth Blood Pressure Monitor GSH885B
Version or Model: GSH885B
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GOLDEN SMART HOME TECHNOLOGY CORP.

Primary DI Number: 04719878120029
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 656002163 *Terms of Use

Device Description: The WowGoHealth Blood Pressure Monitor GSH885B is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22 cm to 32 cm or 22cm to 42cm. It is intended for adult indoor use only. Contraindications: 1. The device is not suitable for use on may be pregnant women or pregnant women. 2. The device is not suitable for use on patients with implanted,electrical devices, such as cardiac pacemakers, defibrillators.

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):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45617	Automatic-inflation electronic sphygmomanometer, portable, arm/wrist	An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXN	System, Measurement, Blood-Pressure, Non-Invasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131395	000

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 5 and 40 Degrees Celsius
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 0 and 93 Percent (%) Relative Humidity

Clinically Relevant Size

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Size Type Text
Length: 154 Millimeter
Width: 106 Millimeter
Height: 57.1 Millimeter

Device Record Status

Public Device Record Key: b347b348-ae28-41e1-8e53-335530791cd6
Public Version Date: November 08, 2019
Public Version Number: 2
DI Record Publish Date: May 17, 2019