Catalog Number

HC385S

Brand Name

Fisher & Paykel Healthcare

Version/Model Number

HC385S

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

K040941,K040941

Product Code

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Public Device Record Key

f4914532-d995-4247-bec3-95b52058f635

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 08, 2016

Package DI Number

09420012416247

Quantity per Package

10

Contains DI Package

09420012429124

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack