Catalog Number

-

Brand Name

DRIVEMEDICAL

Version/Model Number

15011-KING

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

FMW

Product Code Name

COVER, MATTRESS (MEDICAL PURPOSES)

Public Device Record Key

a7dc524b-4d3e-4855-9c2c-cbc894439874

Public Version Date

July 01, 2019

Public Version Number

1

DI Record Publish Date

June 21, 2019

Package DI Number

50822383535673

Quantity per Package

12

Contains DI Package

00822383535678

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-