AccessGUDID - DEVICE: PowerDot (04719872330622)

GUDID

Device Identifier (DI) Information

Brand Name: PowerDot
Version or Model: SAE-MC-PD-01MTBL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ZMI ELECTRONICS LTD.

Primary DI Number: 04719872330622
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 9999
Device Count: 1
Labeler D-U-N-S® Number*: 657406062 *Terms of Use

Device Description: Self-adhesive electrode package (with magnetic snap) , Blue, Each package contains electrode dia.55mm (2pcs) + 50mm*90mm (1pcs)

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?
59689	Neuromuscular transmission electrode	A non-sterile electrical conductor designed to be applied to a patient's body surface, typically the forearm or ankle, to deliver stimulating electrical pulses to a motor nerve or measure electrical impulses from the nerve during neuromuscular transmission (NMT) monitoring. It is typically a disk-like electrode that is affixed to the skin with a special adhesive and a conductive gel (pre-gelled) intended to be used for neuromuscular block monitoring and nerve stimulation for brachial plexus anaesthesia. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GXY	Electrode, Cutaneous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180865	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: dcfecee6-a48e-440f-bade-cc2f99109fce
Public Version Date: December 18, 2019
Public Version Number: 1
DI Record Publish Date: December 10, 2019