AccessGUDID - DEVICE: Alpine BioMed (05704736019163)

GUDID

Device Identifier (DI) Information

Brand Name: Alpine BioMed
Version or Model: 9033A0721CN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Alpine Biomed ApS

Primary DI Number: 05704736019163
Issuing Agency: GS1
Commercial Distribution End Date: April 28, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 311231554 *Terms of Use

Device Description: KP FOCUS PC SYSTEM, UK 230V SPECIAL LABELING FOR CHINA

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

FDA Product Code

[?]

Product Code	Product Code Name
GWF	Stimulator, Electrical, Evoked Response

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: 6694deb4-87ba-4ab0-ad0c-cc7137f651e1
Public Version Date: November 28, 2022
Public Version Number: 4
DI Record Publish Date: August 24, 2016