AccessGUDID - DEVICE: NExT-AMP-ADVANCED (08056446901120)

GUDID

Device Identifier (DI) Information

Brand Name: NExT-AMP-ADVANCED
Version or Model: B9630096005
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EB NEURO SPA

Primary DI Number: 08056446901120
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 339182263 *Terms of Use

Device Description: Acquisition unit of NExT Station Advanced

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:	No
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?
11474	Electromyograph	An electrically-powered unit designed for the measurement and recording of the intrinsic electrical potential of skeletal muscle for display in the form of a graph [electromyograph (EMG)], typically for diagnosis of muscle and/or nerve disorders. It is designed to receive analogue electrical signals from EMG electrodes and process/digitize these signals for viewing, either on an integrated display or for transmission to an off-the-shelf computer.	Active	false
11614	Evoked-potential graphic recording system	An assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from the sensory organs, or within the central nervous system. It typically includes a sensory stimulator/stimulation system and a graphic recorder. The characteristics of the recorded potential vary with recording location, stimulus modality and level, and level of consciousness or anaesthesia. The resultant waveform may be used to assess the function and integrity of the brain and its sensory pathways.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWL	Amplifier, Physiological Signal
OLT	Non-Normalizing Quantitative Electroencephalograph Software
IKN	Electromyograph, Diagnostic
GWE	Stimulator, Photic, Evoked Response
GWF	Stimulator, Electrical, Evoked Response
GWJ	Stimulator, Auditory, Evoked Response

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K242832	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: e4f8a0f7-7a4c-49f6-a745-4e3042989246
Public Version Date: May 30, 2025
Public Version Number: 1
DI Record Publish Date: May 22, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +390554565111
Email: info@ebneuro.com

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