Catalog Number

-

Brand Name

Citadel

Version/Model Number

CX812B3J4AMAD0

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

IOQ

Product Code Name

BED, FLOTATION THERAPY, POWERED

Public Device Record Key

ca6d2c6c-c824-421a-81cd-635ad3f87475

Public Version Date

September 19, 2022

Public Version Number

1

DI Record Publish Date

September 10, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-