Catalog Number

K-3-ESB

Brand Name

K-3 AIRE-ZONE

Version/Model Number

K-3-ESB

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)

-

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

0676d9aa-eb58-440a-89b9-0fe2f09fa117

Public Version Date

August 21, 2020

Public Version Number

1

DI Record Publish Date

August 13, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-