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bellavista 302.323.000-40

by Zoll Medical Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

3 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00198843002920 UDI-DI Date22 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Completed Z-1967-2023 FDA Class II initiated 5 May 2023
    • Completed Z-1966-2023 FDA Class II initiated 5 May 2023

    Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP Hang). When this occurs, if the user continues to interact with the touchscreen, a message will appear that states DeviceSoftware.Application is not responding or a decommission screen will appear on the user interface. The ventilator will issue both an audible and visual alarm. Ventilation continues without interruption with the settings applied prior to the APP Hang error. 2. The potential for a use error has been identified if the operator applies the proposed settings without confirming the settings are suitable for the patient.

    • Terminated Z-0622-2022 FDA Class I initiated 20 Dec 2021

    Potential cessation in ventilation can occur under specific conditions.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
bellavista
Generic Name
Respiration monitor
Model / Reference
302.323.000-40
Primary DI / UDI-DI
00198843002920
510(k) Number
FDA Product Code
CBK
GMDN Term
Respiration monitor
Device Class
Class II
Regulation Number
868.5895
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K183364)

Show all (12)

Other devices from Zoll Medical Corporation

See all devices from Zoll Medical Corporation →

Properties

  • Prescription Use
  • Lot / Batch 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
  • Serial Number: No
  • Expiration Date: No