Nuubo System

Basic Information

• Brand Name: Nuubo System
• Primary DI: 08437011759078
• Version / Model: 2140
• Catalog Number: 2140
• Company Name: SMART SOLUTIONS TECHNOLOGIES SL
• Labeler DUNS: 475359621
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-19
• Public Version: 1
• Public Version Date: 2019-11-27
• Public Version Status: New
• Public Device Record Key: 12e4c5f2-1b8d-49f1-b711-f2171c216236

Device Description

NuuboREC Box USA. Ambulatory ECG monitoring device (Holter) up to 30 days.

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DSH	RECORDER, MAGNETIC TAPE, MEDICAL	Cardiovascular	870.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35162	Electrocardiographic ambulatory recorder	An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08437011759078	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K173461	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 45 Degrees Celsius