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Patient Monitor Rosebud

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06944904085739 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0235-2020 FDA Class II initiated 1 Oct 2019
    • Terminated Z-0238-2020 FDA Class II initiated 1 Oct 2019

    NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Anti-motion feature 2. NIBP hose blockage identification function

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
General-purpose multi-parameter bedside monitor
Model / Reference
Rosebud
Primary DI / UDI-DI
06944904085739
510(k) Number
FDA Product Code
MWI
GMDN Term
General-purpose multi-parameter bedside monitor
Device Class
Class II
Regulation Number
870.2300
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Category: General-purpose multi-parameter bedside monitor

Cleared under the same submission (K132037)

Cleared under the same submission (K221113)

Other devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

See all devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • 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