Catalog Number

8399SL

Brand Name

POSEY

Version/Model Number

8399SL

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

KMI

Product Code Name

Monitor, Bed Patient

Public Device Record Key

2ebe3cf4-f7af-4808-8809-d1336b99a86e

Public Version Date

October 14, 2022

Public Version Number

1

DI Record Publish Date

October 06, 2022

Package DI Number

20190676007930

Quantity per Package

24

Contains DI Package

10190676007933

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case