AccessGUDID - DEVICE: SUDOSCAN (03770025753065)

GUDID

Device Identifier (DI) Information

Brand Name: SUDOSCAN
Version or Model: SUDOTEST
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ADSPHD
Company Name: IMPETO MEDICAL

Primary DI Number: 03770025753065
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 279502673 *Terms of Use

Device Description: SUDOTEST is Hand Smart Electrodes Dock

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):	No
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?
31109	Skin electrical conductance meter	An electronic instrument designed to determine a patient’s electrodermal activity (EDA) [also known as galvanic skin response (GSR), psychogalvanic reflex (PGR), skin conductance response (SCR)] by measuring the electrical conductance of the skin and the tissue path between electrodes placed on the surface of the body (e.g., hands, feet, head), whereby a small electrical current is typically applied. It is used to assess changes in psychophysiological indicators related to autonomic sympathetic activity and emotional states (e.g., fear, startle, pain); sudomotor dysfunction and subsequent reduced EDA have been associated with various conditions (e.g., neuropathy in diabetic patients).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZO	Device, Galvanic Skin Response Measurement

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 5db8255f-64b9-44d6-aaaf-c5dd9de38891
Public Version Date: August 09, 2022
Public Version Number: 1
DI Record Publish Date: August 01, 2022

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: Yes
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: +3314320164020
Email: info@impeto-medical.com

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