Catalog Number

-

Brand Name

Precision Medical Inc.

Version/Model Number

PM15E SERIES

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"

-

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

K930509

Product Code

BTI

Product Code Name

Compressor, Air, Portable

Public Device Record Key

a8f60f13-5ecd-435c-85bd-b35a90a3b120

Public Version Date

April 23, 2021

Public Version Number

3

DI Record Publish Date

February 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-