Duns Number:033147467
Device Description: A hospital grade double electric breast pump, powered by AC or battery power, used to extr A hospital grade double electric breast pump, powered by AC or battery power, used to extract milk from a mother’s breast. The milk will be collected and used to feed infants. The device permits a user to vary the suction strength, and with the use of accessory parts to collect and funnel the breast milk into storage containers. The device utilizes protective measures to prevent the build-up of excessive negative pressure.
Catalog Number
-
Brand Name
Evolve Breast Pump
Version/Model Number
10-0150
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
b2b7f7d3-feeb-4018-a4e7-4c7f8322e104
Public Version Date
January 06, 2020
Public Version Number
2
DI Record Publish Date
July 05, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |