AccessGUDID - DEVICE: Gating Cable - Siemens (EMIP54500150)

GUDID

Device Identifier (DI) Information

Brand Name: Gating Cable - Siemens
Version or Model: Gating Cable - Siemens
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5450015
Company Name: MIPM Mammendorfer Institut für Physik und Medizin GmbH

Primary DI Number: EMIP54500150
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 324416379 *Terms of Use

Device Description: No description.

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?
36005	MRI system synchronizer	A physiological monitoring unit used as a component of a diagnostic magnetic resonance imaging (MRI) system, that produces a signal which enables image formation or data collection to be synchronized with a specific measurable physiological parameter, e.g., the beginning of a patient's respiratory or cardiac cycle. It is primarily used for the purpose of artifact reduction or enhancement of signal-to-noise ratios in various real-time or dynamic MRI applications. It is sometimes referred to as a gated imaging accessory or trigger.	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 [?]
K142032	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: 9309830f-2a12-40e1-9a4f-eb8dd844bfc1
Public Version Date: November 19, 2019
Public Version Number: 1
DI Record Publish Date: November 11, 2019