Catalog Number

-

Brand Name

Heartway Medical Products Co., Ltd

Version/Model Number

PF7

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

K080242

Product Code

INI

Product Code Name

Vehicle, Motorized 3-Wheeled

Public Device Record Key

815cd30a-08df-43ba-9777-562377d439ae

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 23, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-