Catalog Number

8025

Brand Name

PMI Probasics®

Version/Model Number

8025

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"

Yes

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

-

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

1836423a-b7c9-4356-b2cc-65bdf1273041

Public Version Date

May 08, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10841447104053

Quantity per Package

10

Contains DI Package

00841447104056

Package Discontinue Date

May 07, 2019

Package Status

Not in Commercial Distribution

Package Type

CARTON