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MR Patient Care Universal Gating Interface

FDA UDI

Class II (US FDA UDI)

by Philips DS North America LLC

Identity

Trade Name
MR Patient Care Universal Gating Interface FDA UDI
Generic Name
MRI system synchronizer FDA UDI
Model / Reference
Universal Gating Interface FDA UDI

Identifiers

Catalog Number
989803195521 FDA UDI
Primary DI / UDI-DI
00884838056794 FDA UDI
FDA Product Code
MWI FDA UDI
GMDN Term
MRI system synchronizer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: MRI system synchronizer

MR Patient Care Universal Gating Interface by Philips DS North America LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as MRI system synchronizer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Philips DS North America LLC

Sources (1)

  • FDA UDI 5fe55f28-3b5e-4791-9f62-4f265e667e68 34 fields · synced Jun 8, 2026