AccessGUDID - DEVICE: MRI Patient Moitor Tesla DUO (EMIP17000010)

GUDID

Device Identifier (DI) Information

Brand Name: MRI Patient Moitor Tesla DUO
Version or Model: TeslaDUO
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1700001
Company Name: MIPM Mammendorfer Institut für Physik und Medizin GmbH

Primary DI Number: EMIP17000010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 324416379 *Terms of Use

Device Description: The MRI Patient Monitor TeslaDUO is intended for monitoring of vital signs during MRI examinations (MRI procedures) of patients.

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:	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?
61161	MRI-patient physiologic monitoring system	A mobile assembly of devices designed for continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of infant to adult intensive care patients during a magnetic resonance imaging (MRI) procedure. It includes an MRI patient monitor, sensors/electrodes (e.g., ECG electrodes, pulse oximetry telemetric transmitter, blood pressure cuff), and typically an additional remote monitor.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MWI	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153739	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: abe516e2-d13f-49f5-b939-cecf7511623d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 25, 2016