ValueFlow Oral + Nasal Cannula + Filter - Tubing used to detect airflow in sleep studies. - Braebon Medical Corporation

Duns Number:251731105

Device Description: Tubing used to detect airflow in sleep studies.

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More Product Details

Catalog Number

5589-22

Brand Name

ValueFlow Oral + Nasal Cannula + Filter

Version/Model Number

5589-22

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

-

Product Code Details

Product Code

CAT

Product Code Name

Cannula, Nasal, Oxygen

Device Record Status

Public Device Record Key

91fddc27-836d-441c-9aa1-652b6afff8c8

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

October 25, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BRAEBON MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 112