Catalog Number

-

Brand Name

Newtowne Hyperbarics

Version/Model Number

Class 4-31

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2019

Issuing Agency

In GS1

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

-

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

K051759

Product Code

CBF

Product Code Name

Chamber, Hyperbaric

Public Device Record Key

5032e8bf-802d-4340-bc02-7e4da3537ea8

Public Version Date

January 15, 2019

Public Version Number

4

DI Record Publish Date

April 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-