AccessGUDID - DEVICE: ezPad MRI (EMIP53002020)

GUDID

Device Identifier (DI) Information

Brand Name: ezPad MRI
Version or Model: small
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5300202
Company Name: MIPM Mammendorfer Institut für Physik und Medizin GmbH

Primary DI Number: EMIP53002020
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 324416379 *Terms of Use

Device Description: MRI ECG Electrode 70mm x 70mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
35035	Electrocardiographic electrode, single-use	A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRX	Electrode, Electrocardiograph

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
Storage Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b135e8c3-bee0-4fd7-af5f-7c7d45ae7b29
Public Version Date: April 17, 2020
Public Version Number: 2
DI Record Publish Date: October 23, 2018