BB-613 H@H kit

Basic Information

• Brand Name: BB-613 H@H kit
• Primary DI: 07290020154309
• Version / Model: 2.1.0
• Catalog Number: BB90000200003
• Company Name: BIOBEAT TECHNOLOGIES LTD
• Labeler DUNS: 532193771
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-05
• Public Version: 1
• Public Version Date: 2025-03-13
• Public Version Status: New
• Public Device Record Key: 1b48114c-4b92-4b6a-885d-f17effe3b9ac

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQA	Oximeter	Cardiovascular	870.2700	2
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	870.1130	2
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	870.2910	2
BZQ	Monitor, Breathing Frequency	Anesthesiology	868.2375	2
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	870.1435	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290020154309	GS1

Premarket Submissions

Submission Number	Supplement Number
K222010	000