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Expression MR400 MRI Patient Monitoring System (Model MR400)

FDA UDI

Class II (US FDA UDI)

by Philips DS North America LLC

Identity

Trade Name
Expression MR400 MRI Patient Monitoring System (Model MR400) FDA UDI
Generic Name
General-purpose multi-parameter bedside monitor FDA UDI
Device Name
Bundled accessories to be used with the Expression MR400 MRI Patient Monitor. FDA UDI
Model / Reference
Expression MR400 Accessories FDA UDI
Description
Bundled accessories to be used with the Expression MR400 MRI Patient Monitor. FDA UDI

Identifiers

Catalog Number
866428 FDA UDI
Primary DI / UDI-DI
00884838056312 FDA UDI
FDA Product Code
MWI FDA UDI
GMDN Term
General-purpose multi-parameter bedside monitor 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

Category: General-purpose multi-parameter bedside monitor

Expression MR400 MRI Patient Monitoring System (Model MR400) by Philips DS North America LLC — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as General-purpose multi-parameter bedside monitor.

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 cd8071f7-72cb-4f2a-816b-e91e8ffd3b5d 36 fields · synced Jun 8, 2026