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Patient Monitor Passport 8

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

2 ongoing

This device is named in the recall

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 Number06944904085692 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0115-2027 FDA Class III initiated 31 Aug 2026
    • Ongoing Z-0114-2027 FDA Class III initiated 31 Aug 2026

    Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

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  • Withdrawn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
Passport 8
Primary DI / UDI-DI
06944904085692
510(k) Number
FDA Product Code
MHX
GMDN Term
General-purpose multi-parameter bedside monitor
Device Class
Class II
Regulation Number
870.1025
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Category: General-purpose multi-parameter bedside monitor

Cleared under the same submission (K153448)

Show all (12)

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