Catalog Number

4010

Brand Name

PMI Probasics®

Version/Model Number

4010

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 14, 2016

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FNL

Product Code Name

Bed, Ac-Powered Adjustable Hospital

Public Device Record Key

a26047c3-ab3b-466b-bf05-e11f92e88910

Public Version Date

September 17, 2018

Public Version Number

3

DI Record Publish Date

March 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-