Catalog Number

-

Brand Name

DRIVEMEDICAL

Version/Model Number

B11144-001

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

BZD

Product Code Name

VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Public Device Record Key

414ee250-1093-446e-8807-6d772acdf864

Public Version Date

July 01, 2019

Public Version Number

1

DI Record Publish Date

June 21, 2019

Package DI Number

50822383296208

Quantity per Package

100

Contains DI Package

00822383296203

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-