Identity
- Trade Name
- Monarch™ Bronchoscope System FDA UDI
- Generic Name
- Flexible video bronchoscope, single-use FDA UDI
- Device Name
- Monarch™ Bronchoscope System FDA UDI
- Model / Reference
- MBR-000011 FDA UDI
- Description
- Monarch™ Bronchoscope System FDA UDI
Identifiers
- Catalog Number
- MBR-000011 FDA UDI
- Primary DI / UDI-DI
- B634MBR0000110 FDA UDI
- 510(k) Number
- K173760 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- GMDN Term
- Flexible video bronchoscope, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4680 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flexible video bronchoscope, single-use
Monarch™ Bronchoscope System by Auris Health, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video bronchoscope, single-use.
- aScope™ 5 Broncho HD 5.0/2.2 Sampler Set — Ambu A/S · Class II
- aScope™ 4 Broncho Slim 3.8/1.2 — Ambu A/S · Class II
- Single-Use flexible Video Bronchoscope — HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD. · Class II
- aScope™ 4 Broncho Large 5.8/2.8 — Ambu A/S · Class II
- Single-Use flexible Video Bronchoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- aScope™ 5 Broncho 4.2/2.2 Sampler Set — Ambu A/S · Class II
- Single-Use flexible Video Bronchoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- GlideScope® — Verathon Medical (Canada) ULC · Class II
Cleared under the same submission
K173760 also covers:
- Biopsy Forceps - Smooth Cup — Auris Health, Inc
- Bronchoscope Fluidics Tubing — Auris Health, Inc
- Bronchoscope Patient Introducer Kit — Auris Health, Inc
- Bronchoscope Sheath Valve — Auris Health, Inc
- Bronchoscope Sheath Valve — Auris Health, Inc
- Bronchoscope Valve — Auris Health, Inc
- Cytology Brush — Auris Health, Inc
- Monarch Endoscopy Platform (P1) Tower Upgrade — Auris Health, Inc
- Monarch Software Laptop v2.1.6 — Auris Health, Inc
- Monarch Software Laptop v2.2.1 — Auris Health, Inc
- Monarch Software Tower v2.1.6 — Auris Health, Inc
- Monarch™ Platform — Auris Health, Inc
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Auris Health, Inc
Sources (1)
- FDA UDI 51249d3b-b127-4ed2-9b09-3da9af09a991 35 fields · synced Jun 4, 2026