Catalog Number

-

Brand Name

Mölnlycke®Z-Flo™ Fluidized Positioner

Version/Model Number

1400403

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

6c90d9da-b02d-4b12-bfdc-250b091603a6

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 21, 2022

Package DI Number

07323190226535

Quantity per Package

6

Contains DI Package

07323190236626

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE