Catalog Number

-

Brand Name

Precision Medical Inc.

Version/Model Number

PM3400 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

K944479

Product Code

KDP

Product Code Name

Regulator, Vacuum

Public Device Record Key

7d3a14fb-b939-4721-aed6-14170cfad1b7

Public Version Date

April 22, 2021

Public Version Number

5

DI Record Publish Date

February 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-