Catalog Number

8011

Brand Name

PMI Probasics®

Version/Model Number

8011

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 07, 2019

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

K043238,K043238

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

31dd9d9d-35cd-46cd-a127-c1428c3cdad4

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

10841447104046

Quantity per Package

6

Contains DI Package

00841447104049

Package Discontinue Date

May 07, 2019

Package Status

Not in Commercial Distribution

Package Type

CARTON