AccessGUDID - DEVICE: BB-613W Wrist-Monitor (07290020154101)

GUDID

Device Identifier (DI) Information

Brand Name: BB-613W Wrist-Monitor
Version or Model: 1.1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BB90000100000
Company Name: BIOBEAT TECHNOLOGIES LTD

Primary DI Number: 07290020154101
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532193771 *Terms of Use

Device Description: No description.

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:	Yes
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?
57960	Multiple physiological parameter spot-check system, clinical	An electrically-powered device assembly designed for professional use in a clinical setting to spot-check (user-initiated) measure and display multiple patient physiological parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2), blood glucose]; it has no continuous monitoring capability or programmable alarm features. It typically includes a main analysis unit with a visual display and ports for input of the system's measuring components (e.g., thermometer, blood pressure cuff, SpO2 probe, spirometer), and potentially in vitro diagnostic [IVD] analysers (e.g., clinical chemistry analyser, urine analyser).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQA	Oximeter
DXN	System, Measurement, Blood-Pressure, Non-Invasive
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency
BZQ	Monitor, Breathing Frequency
FLL	Thermometer, Electronic, Clinical
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K222010	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: 2f6f589a-58bb-4afb-aa23-6fdac5c1b4e4
Public Version Date: March 13, 2025
Public Version Number: 1
DI Record Publish Date: March 05, 2025