Monarch Bronchoscope MRB-000211-A

GUDID B634MBR000211A1

AURIS HEALTH, INC.

Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use

Primary Device ID	B634MBR000211A1
NIH Device Record Key	7fbda138-323c-4228-a398-7c270edf70cd
Commercial Distribution Status	In Commercial Distribution
Brand Name	Monarch Bronchoscope
Version Model Number	MBR-000211-A
Catalog Number	MRB-000211-A
Company DUNS	015823456
Company Name	AURIS HEALTH, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B634MBR000211A0 [Primary]
HIBCC	B634MBR000211A1 [Package] Contains: B634MBR000211A0 Package: Box [1 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K193534

FDA Product Code

EOQ	Bronchoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-05-13
Device Publish Date	2021-05-05

On-Brand Devices [Monarch Bronchoscope]

B623MBR000211A0	Monarch Bronchoscope
B634MBR000211A1	MBR-000211-A
B634MBR000211B1	Monarch Bronchoscope