Catalog Number

-

Brand Name

Precision Medical Inc.

Version/Model Number

PM5480

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

K090781

Product Code

BZR

Product Code Name

Mixer, Breathing Gases, Anesthesia Inhalation

Public Device Record Key

0984931a-df7c-4854-bb43-e7e170813a18

Public Version Date

April 22, 2021

Public Version Number

4

DI Record Publish Date

December 17, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-