Catalog Number

-

Brand Name

Precision Medical Inc.

Version/Model Number

PM500

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

Yes

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

K902970,K902970

Product Code

BTT

Product Code Name

Humidifier, Respiratory Gas, (Direct Patient Interface)

Public Device Record Key

3d3493ae-4e5f-4aa8-810e-ba0f2589ccaf

Public Version Date

March 02, 2021

Public Version Number

2

DI Record Publish Date

March 27, 2020

Package DI Number

00855887006931

Quantity per Package

50

Contains DI Package

00855887006924

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE