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Bedrail hook TDS handle 115-021120-00

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

1 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 Number06944904086279 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-2549-2016 FDA Class II initiated 23 Jun 2016

    Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Bedrail hook TDS handle
Generic Name
General-purpose multi-parameter bedside monitor
Model / Reference
115-021120-00
Primary DI / UDI-DI
06944904086279
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 (K143195)

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
  • Manufacturing Date

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
  • Serial Number: No
  • Expiration Date: No