AccessGUDID - DEVICE: MEDALink (G096MMR5VPR0500)

GUDID

Device Identifier (DI) Information

Brand Name: MEDALink
Version or Model: M-MR-5VPR-050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M-MR-5VPR-050
Company Name: Rising Eagle Medical LLC

Primary DI Number: G096MMR5VPR0500
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080145608 *Terms of Use

Device Description: 5 VLead, Pinch, Reusable, Mindray Compatible, 50in, ECG Leadwire, AHA/AAMI, 1/EA

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":	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?
35562	Electrocardiographic lead set, reusable	A collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKD	Cable, Electrode

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: 310cd5f0-c0dc-4843-bc5b-92e12e0b30f3
Public Version Date: August 05, 2024
Public Version Number: 1
DI Record Publish Date: July 27, 2024