Catalog Number

-

Brand Name

HAEMONETICS SMARTSUCTION HARMONY SYSTEM

Version/Model Number

HAR-A-1001

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

Yes

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

K052626,K052626

Product Code

BTA

Product Code Name

Pump, Portable, Aspiration (Manual Or Powered)

Public Device Record Key

15032163-c571-49dc-82a1-a10fe3c91a7a

Public Version Date

January 08, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

30812747017347

Quantity per Package

10

Contains DI Package

10812747017343

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton