MediByte Patient Kit - Consumables to be used with the MediByte. The - Braebon Medical Corporation

Duns Number:251731105

Device Description: Consumables to be used with the MediByte. The single-use kit contains: 3.6 V 1/2 AA Lithiu Consumables to be used with the MediByte. The single-use kit contains: 3.6 V 1/2 AA Lithium Battery, 8597 Oronasal cannula and Micropore tape.

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More Product Details

Catalog Number

8119-5

Brand Name

MediByte Patient Kit

Version/Model Number

8119-5

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

273d8fa7-823c-4980-849e-d9d965d46ea3

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

November 08, 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