Catalog Number

63.00.509

Brand Name

Alyssa

Version/Model Number

63.00.509

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K212773,K212773

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Public Device Record Key

cbebb542-67c4-41be-be94-10c60a0e1aa2

Public Version Date

August 17, 2022

Public Version Number

1

DI Record Publish Date

August 09, 2022

Package DI Number

07640108053541

Quantity per Package

4

Contains DI Package

07640108053534

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box