BRAEBON Disposable RIP Belt, Medium - Disposable belt intended for use during sleep - Braebon Medical Corporation

Duns Number:251731105

Device Description: Disposable belt intended for use during sleep disorder studies as a measure of respirator Disposable belt intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.

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More Product Details

Catalog Number

5572-24

Brand Name

BRAEBON Disposable RIP Belt, Medium

Version/Model Number

5572-24

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

K001743,K001743

Product Code Details

Product Code

BZQ

Product Code Name

Monitor, Breathing Frequency

Device Record Status

Public Device Record Key

801024eb-ec66-46d7-b23d-1ede1ec4f61b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

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