Catalog Number

3001016

Brand Name

TheraFlo M-set 48'' × 80'' QLT Recover

Version/Model Number

S2001-2180

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

886c3d8d-ecf2-405d-8129-2536a9d6254a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-