Catalog Number

-

Brand Name

DRIVEMEDICAL

Version/Model Number

680640

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

709eb0b1-9daf-4aae-8efa-e7e75f17d9cf

Public Version Date

July 01, 2019

Public Version Number

1

DI Record Publish Date

June 21, 2019

Package DI Number

50822383525711

Quantity per Package

10

Contains DI Package

00822383525716

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-