AccessGUDID - DEVICE: Nuubo System (08437011759016)

GUDID

Device Identifier (DI) Information

Brand Name: Nuubo System
Version or Model: 2020
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2020
Company Name: SMART SOLUTIONS TECHNOLOGIES SL

Primary DI Number: 08437011759016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 475359621 *Terms of Use

Device Description: Nuubo30 SI Box USA. Textile with an integrated electrodes technology for sensing the patient’s ECG.

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	Yes
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?
61821	Electrocardiographic lead set, single-use	A collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array to assist electrode placement. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSH	RECORDER, MAGNETIC TAPE, MEDICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173461	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
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 90321852-9fe5-44c1-b63e-385a1b5684ad
Public Version Date: June 06, 2024
Public Version Number: 2
DI Record Publish Date: November 15, 2019