Identity
- Trade Name
- Bronchoscope Sheath Valve FDA UDI
- Generic Name
- Endoscope channel support kit FDA UDI
- Device Name
- Bronchoscope Sheath Valve FDA UDI
- Model / Reference
- MBR-000020 FDA UDI
- Description
- Bronchoscope Sheath Valve FDA UDI
Identifiers
- Catalog Number
- MBR-000020 FDA UDI
- Primary DI / UDI-DI
- B634MBR0000200 FDA UDI
- 510(k) Number
- K173760 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- GMDN Term
- Endoscope channel support kit 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscope channel support kit
Bronchoscope Sheath Valve by Auris Health, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope channel support kit.
- Check-Flo — COOK INCORPORATED · Class II
- 4-Piece Valve Kit — Micro-tech Usa · Class II
- CeroFrict — SML Med-Tech Solutions Limited · Class II
- CeroFrict — SML Med-Tech Solutions Limited · Class II
- Air Water Channel Cleaning Adapter + Champion 4-piece Valve Kit — GA Health Company Limited · Class II
- 5-Piece Valve Kit — Micro-tech Usa · Class II
- Disposable Endoscopy Adapter Set — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class II
- CeroFrict — SML Med-Tech Solutions Limited · 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 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™ Bronchoscope System — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Auris Health, Inc
Sources (1)
- FDA UDI e90f3472-f75c-4d02-aaf0-c38afb0431be 35 fields · synced Jun 4, 2026