AccessGUDID - DEVICE: GATING CABLE, SIEMENS (00884838045101)

GUDID

Device Identifier (DI) Information

Brand Name: GATING CABLE, SIEMENS
Version or Model: CAB,GATING,SIEMENS,3160
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 9291
Company Name: Philips Ds North America LLC

Primary DI Number: 00884838045101
Issuing Agency: GS1
Commercial Distribution End Date: December 15, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 013649151 *Terms of Use

Device Description: CAB,GATING,SIEMENS,3160

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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 [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Atmospheric Pressure: between 708 and 1020 millibar
Storage Environment Atmospheric Pressure: between 70.8 and 102 KiloPascal
Storage Environment Atmospheric Pressure: between 531 and 765 Millimeter of Mercury
Storage Environment Humidity: between 15 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dd078fec-8e2b-4c92-aeae-40e67d6b3422
Public Version Date: February 01, 2024
Public Version Number: 6
DI Record Publish Date: April 11, 2019