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ID adapter update kit(RJ45+D cable) 115-015296-00

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

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06944904036427 UDI-DIDate23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

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.

Specification

GUDID

Trade Name
ID adapter update kit(RJ45+D cable)
Generic Name
General-purpose multi-parameter bedside monitor
Model / Reference
115-015296-00
Primary DI / UDI-DI
06944904036427
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