Duns Number:827221698
Device Description: Double Electric Breast Pump
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
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
HGX
Product Code Name
Pump, Breast, Powered
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
Package DI Number
40092237615292
Quantity per Package
4
Contains DI Package
00092237615294
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
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 |