Catalog Number

-

Brand Name

PURE ENRICHMENT

Version/Model Number

PEBRPUMP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Public Device Record Key

ab979772-06ef-4e58-8dae-1f6b6e3914de

Public Version Date

July 27, 2020

Public Version Number

2

DI Record Publish Date

December 03, 2018

Package DI Number

B311PEBRPUMP1

Quantity per Package

12

Contains DI Package

B311PEBRPUMP0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

MASTER CARTON