AccessGUDID - DEVICE: Xavant Technology (06009880396160)

GUDID

Device Identifier (DI) Information

Brand Name: Xavant Technology
Version or Model: NMBA Cable with accelerometer (3.5m)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: XT-45015A
Company Name: XAVANT TECHNOLOGY (PTY) LTD

Primary DI Number: 06009880396160
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 639571707 *Terms of Use

Device Description: Neuromuscular blocking agent monitoring cable (3.5 m) with three dimensional acceleromyography.

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?
35729	Diagnostic peripheral nerve electrical stimulation system	An assembly of devices designed to apply electrical stimuli in one peripheral region of the body while the response is monitored in another peripheral region. It typically consists of external electrodes (e.g., hand-held bipolar or ring electrodes) or needle electrodes and a pulse generator. It is used for the stimulation of a peripheral nerve or muscle in motor-nerve conduction studies (e.g., the posterior tibial nerve), and/or in sensory-nerve conduction studies (e.g., the ulnar nerve) performed during clinical electrophysiology (EP) assessments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BXN	Stimulator, Nerve, Battery-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102084	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: less than 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9f9550ab-6fac-4bfb-b28f-997db3ae64b7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 10, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
16009880396167	1	06009880396160	In Commercial Distribution	Box
26009880396164	2	16009880396167	In Commercial Distribution	Box
36009880396161	5	26009880396164	In Commercial Distribution	Box
46009880396168	2	36009880396161	In Commercial Distribution	Box