AccessGUDID - DEVICE: MARNUR Blood Pressure Monitor (06971508420000)

GUDID

Device Identifier (DI) Information

Brand Name: MARNUR Blood Pressure Monitor
Version or Model: TMB-1583
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhenshi Dingqian E-Commerce Co.,Ltd.

Primary DI Number: 06971508420000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544580789 *Terms of Use

Device Description: The MARNUR Blood Pressure Monitor TMB-1583 is digital monitor intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22 cm to 42 cm (about 8¾˝-16½˝). It is intended for adult indoor use only.

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

[?]

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 [?]
K120058	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
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 10 and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 86 and 106 KiloPascal
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Handling Environment Humidity: between 0 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Weight: 250 Gram
Height: 118 Millimeter
Width: 103 Millimeter
Length: 107 Millimeter

Device Record Status

Public Device Record Key: 2a1ace77-3245-4d06-9b88-b236dd9b042f
Public Version Date: November 08, 2019
Public Version Number: 4
DI Record Publish Date: January 25, 2018