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MONARCH™ Bronchoscope MBR-000211-B

by Auris Health, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10810068811138 UDI-DI Date21 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0543-2026 FDA Class II initiated 18 Oct 2025

    Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
MONARCH™ Bronchoscope
Generic Name
Flexible video bronchoscope, reusable
Model / Ref / Catalog
MBR-000211-B
Primary DI / UDI-DI
10810068811138
510(k) Number
FDA Product Code
QNW
GMDN Term
Flexible video bronchoscope, reusable
Device Class
Class II
Regulation Number
874.4680
GUDID distribution status
In Commercial Distribution

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Serial Number
  • Expiration Date

Other properties (9)

  • 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
  • Manufacturing Date: No