Duns Number:004135503
Device Description: Dual Electric Breast Pump with dual phase design, individual control, and multi-level suct Dual Electric Breast Pump with dual phase design, individual control, and multi-level suction control.
Catalog Number
-
Brand Name
Clever Choice
Version/Model Number
SDI-BP6100
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
d3b25366-1562-4869-bc90-9899136841e4
Public Version Date
November 01, 2019
Public Version Number
2
DI Record Publish Date
September 25, 2018
Package DI Number
10898302001873
Quantity per Package
5
Contains DI Package
00898302001876
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |