Catalog Number

-

Brand Name

Roscoe Medical

Version/Model Number

NEB-SIERRA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

Yes

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

-

Product Code

BTI

Product Code Name

Compressor, Air, Portable

Public Device Record Key

3dadfceb-6274-41c5-84fc-45389c35bc0a

Public Version Date

May 23, 2019

Public Version Number

3

DI Record Publish Date

October 05, 2016

Package DI Number

60092237613926

Quantity per Package

6

Contains DI Package

00092237613924

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA