AccessGUDID - DEVICE: Heartsync by Vermed (00009336010080)

GUDID

Device Identifier (DI) Information

Brand Name: Heartsync by Vermed
Version or Model: T100LOAC-SCILLER
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6600263H
Company Name: GRAPHIC CONTROLS ACQUISITION CORP

Primary DI Number: 00009336010080
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002111896 *Terms of Use

Device Description: DEFIB ELECTRODE

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):	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?
11130	Electrode conductive skin pad, single-use	A noninvasive conductive material designed to facilitate electrical conduction between an external electrode (e.g., paddle-type defibrillator electrode) and the skin surface. It is available in various forms such as a thickened gel or polymer medium reinforced by a non-woven material, an adhesive pad/patch, or an absorbent material (e.g., felt) intended to be soaked in a conduction fluid. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MLN	Electrode, Electrocardiograph, Multi-Function

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
Storage Environment Temperature: between 50 and 104 Degrees Fahrenheit
Storage Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 11e599a9-29e5-4d1c-b259-1ee02983f133
Public Version Date: February 20, 2023
Public Version Number: 3
DI Record Publish Date: November 06, 2020