Catalog Number

-

Brand Name

DK50 DE

Version/Model Number

ADV 230V/50Hz 3 bar NO SLE

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2017

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K091871

Product Code

BTI

Product Code Name

Compressor, Air, Portable

Public Device Record Key

4851c263-2b1b-4a8c-8ed3-187babbae46f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-