Bronchoscope Fluidics Tubing - Bronchoscope Fluidics Tubing - AURIS HEALTH, INC.

Duns Number:015823456

Device Description: Bronchoscope Fluidics Tubing

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More Product Details

Catalog Number

MBR-000218

Brand Name

Bronchoscope Fluidics Tubing

Version/Model Number

MBR-000218

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K173760

Product Code Details

Product Code

EOQ

Product Code Name

Bronchoscope (Flexible Or Rigid)

Device Record Status

Public Device Record Key

00a9ff69-263c-4105-bd1d-359d9cfa16b1

Public Version Date

November 23, 2021

Public Version Number

1

DI Record Publish Date

November 15, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AURIS HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 37