AccessGUDID - DEVICE: 1BYONE (00863696000309)

GUDID

Device Identifier (DI) Information

Brand Name: 1BYONE
Version or Model: TMB-1585
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: 1BYONE PRODUCTS INC.

Primary DI Number: 00863696000309
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 845019202 *Terms of Use

Device Description: Arm blood pressure monitor

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Telemetric sphygmomanometer	A battery-powered device, typically digital, designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic limb-cuff inflation and measurement cycles. Current heart rate and mean arterial pressure, in addition to systolic and diastolic blood pressures, are subsequently displayed and radio transmitted by the device to a monitoring site, therefore obviating the need for cabling and promoting the patient's freedom of movement.

GMDN Preferred Term Name

GMDN Definition

Telemetric sphygmomanometer

A battery-powered device, typically digital, designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic limb-cuff inflation and measurement cycles. Current heart rate and mean arterial pressure, in addition to systolic and diastolic blood pressures, are subsequently displayed and radio transmitted by the device to a monitoring site, therefore obviating the need for cabling and promoting the patient's freedom of movement.

FDA Product Code

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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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 41574f87-88ab-477a-b881-eb23561a047e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 19, 2016