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Essential MRI Patient Monitor (Model 865353)

by Philips Ds North America LLC

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 19 Oct 2026. What this means

Regulatory status

as of registry sync 19 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00884838012585 UDI-DI Date30 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Pulse oximeter
Model / Ref / Catalog
Essential MRI Patient Monitor, 865353
Primary DI / UDI-DI
00884838012585
FDA Product Code
DQA
GMDN Term
Pulse oximeter
Device Class
Class II
Regulation Number
870.2700
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Conditional

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Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No