Viverity - Double Electric Breast Pump - COMPASS HEALTH BRANDS CORP.

Duns Number:827221698

Device Description: Double Electric Breast Pump

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More Product Details

Catalog Number

-

Brand Name

Viverity

Version/Model Number

DBEL-WBAG

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Device Record Status

Public Device Record Key

04bb9574-aa4f-4052-8a56-fdbe9f3813f8

Public Version Date

May 23, 2019

Public Version Number

3

DI Record Publish Date

October 05, 2016

Additional Identifiers

Package DI Number

40092237615292

Quantity per Package

4

Contains DI Package

00092237615294

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA

"COMPASS HEALTH BRANDS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 62
2 A medical device with a moderate to high risk that requires special controls. 273
U Unclassified 2