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Universal Gating Interface

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 989803195521

by Invivo, a division of Philips Medical Systems

Identity

Trade Name
Universal Gating Interface EUDAMED
MR Patient Care Universal Gating Interface FDA UDI
Generic Name
MRI system synchronizer FDA UDI
Device Name
Reusable Gating Cables EUDAMED
Gating cable for use between any Expression MR patient monitor and any wired or wireless MRI system accessories. FDA UDI
Model / Reference
989803195521 EUDAMED
Universal Gating Interface FDA UDI
Description
Gating cable for use between any Expression MR patient monitor and any wired or wireless MRI system accessories. FDA UDI

Identifiers

Catalog Number
989803195521 FDA UDI
Primary DI / UDI-DI
00884838103672 EUDAMEDFDA UDI
Basic UDI-DI
0884838BM458TD EUDAMED
FDA Product Code
MWI FDA UDI
EMDN Code
Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
GMDN Term
MRI system synchronizer FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
870.2300 FDA UDI
Market of Registration
Austria EUDAMED
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Universal Gating Interface by Invivo, a division of Philips Medical Systems — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Invivo, a division of Philips Medical Systems
EUDAMED SRN
US-MF-000002177
Authorised Representative
Philips Medizin Systeme Böblingen GmbH DE-AR-000006030

Sources (2)

  • EUDAMED 916cdbf1-e52c-4253-950b-a51785d16b36 61 fields · synced Oct 6, 2026
  • FDA UDI 681795cf-41a9-41af-8238-556889306d67 37 fields · synced May 30, 2026