Catalog Number

-

Brand Name

RecoveryAir

Version/Model Number

RecoveryAir Prime Pump

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

IRP

Product Code Name

Massager, Powered Inflatable Tube

Public Device Record Key

bb87f28d-c3d9-484a-89f7-cefb24751f60

Public Version Date

December 31, 2021

Public Version Number

1

DI Record Publish Date

December 23, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-