Catalog Number

BPW02-19

Brand Name

Wipe Down Bariatric Body Wedge Set

Version/Model Number

BPW02-19

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

FMP

Product Code Name

Protector, Skin Pressure

Public Device Record Key

1dfce7dd-af0e-4ecf-b846-02bb51c6e9a2

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 20, 2019

Package DI Number

00810006682830

Quantity per Package

4

Contains DI Package

00810006681406

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE