Catalog Number

8005

Brand Name

POSEY

Version/Model Number

8005

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

57166c44-e700-4320-90cb-1a15f6cbbdfa

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

September 13, 2016

Package DI Number

20190676000535

Quantity per Package

2

Contains DI Package

10190676000538

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS