BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

MR Patient Care Universal Gating Interface

DI: 00884838120303 · Model: Universal Gating Interface · Philips Medizin Systeme Böblingen GmbH

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: MR Patient Care Universal Gating Interface
Primary DI: 00884838120303
Version / Model: Universal Gating Interface
Catalog Number: 989803195521
Company Name: Philips Medizin Systeme Böblingen GmbH
Labeler DUNS: 314101143
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2025-07-24
Public Version: 1
Public Version Date: 2025-08-01
Public Version Status: New
Public Device Record Key: 343dc55f-c792-418a-81a8-e3d5328f9cbb

Device Description

Gating cable for use between any Expression MR patient monitor and any wired or wireless MRI system accessories.

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: MR Conditional
Direct Marking Exempt: Yes
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838120303	GS1

Storage Conditions

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