Bronchoscope Sheath Valve MBR-000020

GUDID B634MBR0000200

Bronchoscope Sheath Valve

AURIS HEALTH, INC.

Endoscope channel support kit Endoscope channel support kit
Primary Device IDB634MBR0000200
NIH Device Record Keye90f3472-f75c-4d02-aaf0-c38afb0431be
Commercial Distribution StatusIn Commercial Distribution
Brand NameBronchoscope Sheath Valve
Version Model NumberMBR-000020
Catalog NumberMBR-000020
Company DUNS015823456
Company NameAURIS HEALTH, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB634MBR0000200 [Primary]
HIBCCB634MBR0000201 [Package]
Package: Box [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOQBronchoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-09
Device Publish Date2018-06-08

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