Nuubo System 2140

GUDID 08437011759078

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

SMART SOLUTIONS TECHNOLOGIES SL

Electrocardiographic ambulatory recorder
Primary Device ID08437011759078
NIH Device Record Key12e4c5f2-1b8d-49f1-b711-f2171c216236
Commercial Distribution StatusIn Commercial Distribution
Brand NameNuubo System
Version Model Number2140
Catalog Number2140
Company DUNS475359621
Company NameSMART SOLUTIONS TECHNOLOGIES SL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+34678078697
Email[email protected]

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108437011759078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSHRECORDER, MAGNETIC TAPE, MEDICAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-27
Device Publish Date2019-11-19

On-Brand Devices [Nuubo System]

08437011759030Nuubo30 SIII Box USA. Textile with an integrated electrodes technology for sensing the patient’s ECG.
08437011759023Nuubo30 SII Box USA. Textile with an integrated electrodes technology for sensing the patient’s ECG.
08437011759016Nuubo30 SI Box USA. Textile with an integrated electrodes technology for sensing the patient’s ECG.
08437011759078NuuboREC Box USA. Ambulatory ECG monitoring device (Holter) up to 30 days.

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