Catalog Number

-

Brand Name

Posey

Version/Model Number

RM-8309EL

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

Yes

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

PJO

Product Code Name

Fall Prevention Alarm/Sensor Combination Attached Or Unattached

Public Device Record Key

47c89286-2929-4a01-891f-c056f2ce4efc

Public Version Date

August 26, 2022

Public Version Number

1

DI Record Publish Date

August 18, 2022

Package DI Number

10816317024045

Quantity per Package

6

Contains DI Package

00816317024048

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case