AccessGUDID - DEVICE: Pharmaceutical Innovations (00300363000557)

GUDID

Device Identifier (DI) Information

Brand Name: Pharmaceutical Innovations
Version or Model: LECTRON II Electrode Conductivity Gel
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 36-3000-55
Company Name: PHARMACEUTICAL INNOVATIONS INC

Primary DI Number: 00300363000557
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 067486548 *Terms of Use

Device Description: LECTRON II Electrode Conductivity Gel: 55 Gallon Drum

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:	Yes
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?
11425	Electrode conductive medium	A non-sterile substance intended to be used as a medium for the efficient transmission of electrical signals between an electrode and the body, and for the reduction of the isolation properties of the skin. It is typically in the form of a gel, paste, spray or cream and is usually used in electrocardiography, defibrillation and diathermy. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GYB	Media, Electroconductive

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: c884dc5e-0f87-4d81-bdec-80b0cd81f958
Public Version Date: October 22, 2018
Public Version Number: 3
DI Record Publish Date: September 14, 2016