MR Patient Care Universal Gating Interface

Basic Information

• Brand Name: MR Patient Care Universal Gating Interface
• Primary DI: 00884838103672
• Version / Model: Universal Gating Interface
• Catalog Number: 989803195521
• Company Name: Philips Ds North America LLC
• Labeler DUNS: 013649151
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-25
• Public Version: 4
• Public Version Date: 2024-02-01
• Public Version Status: Update
• Public Device Record Key: 681795cf-41a9-41af-8238-556889306d67

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: No
• 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	00884838103672	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

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: 531 – 765 Millimeter of Mercury
• Type: Storage Environment Humidity
• Temperature Range: 15 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70.8 – 102 KiloPascal