Catalog Number

-

Brand Name

Healcan

Version/Model Number

S12

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

K212180,K212180

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Public Device Record Key

e1f12b36-4d76-4d4b-9749-bd5b72cad3b2

Public Version Date

July 25, 2022

Public Version Number

1

DI Record Publish Date

July 15, 2022

Package DI Number

06973493594858

Quantity per Package

32

Contains DI Package

06973493590850

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton