Catalog Number

HD60-1007

Brand Name

HUMAN DESIGN MEDICAL

Version/Model Number

US

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

K140929

Product Code

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Public Device Record Key

e04c329a-f964-4bbf-a9df-a2ba297555eb

Public Version Date

April 19, 2019

Public Version Number

4

DI Record Publish Date

July 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-