Catalog Number

8021

Brand Name

POSEY

Version/Model Number

8021

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

0fc8a19a-4e83-4416-ba9f-6ab5f8ab2602

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 13, 2016

Package DI Number

20190676000559

Quantity per Package

1

Contains DI Package

10190676000552

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS