AccessGUDID - DEVICE: Vermed (00009336009381)

GUDID

Device Identifier (DI) Information

Brand Name: Vermed
Version or Model: IPC71041-8M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 32029522
Company Name: GRAPHIC CONTROLS ACQUISITION CORP

Primary DI Number: 00009336009381
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002111896 *Terms of Use

Device Description: IP Set ECG Adapter Cables

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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":	Yes
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?
36349	Patient monitoring system module, electrocardiographic	A small unit dedicated to the detection, measurement, and recording of the electrical activity of the heart in the form of an electrocardiogram (ECG) obtained through cables/leads connected to the patient. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the ECG parameter/information measured and provided by this module.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101685	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: ea55a811-5546-426b-be33-140c6d7404b0
Public Version Date: November 12, 2018
Public Version Number: 1
DI Record Publish Date: October 10, 2018