Catalog Number

8300PL

Brand Name

PMI Probasics®

Version/Model Number

8300PL

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

-

Product Code

NFB

Product Code Name

Conserver, Oxygen

Public Device Record Key

7cc87822-889c-43b0-9698-16065e497dfd

Public Version Date

May 08, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-