AccessGUDID - DEVICE: STIMPOD (06009880396429)

GUDID

Device Identifier (DI) Information

Brand Name: STIMPOD
Version or Model: NMT Monitoring Cable AMG (3.0m)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: XT-45025B
Company Name: XAVANT TECHNOLOGY (PTY) LTD

Primary DI Number: 06009880396429
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 (3.0m) using acceleromyography. Accessory to be used with the STIMPOD NMS450 Nerve Stimulator.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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 [?]
K213049	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 Temperature: between 0 and 50 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a7c526c4-9fbf-4e29-bf5f-e462c57a70af
Public Version Date: November 25, 2024
Public Version Number: 1
DI Record Publish Date: November 15, 2024