Duns Number:489122720
Device Description: Powered breast pump consisting of a motor unit with a press-button user interface, and 1 e Powered breast pump consisting of a motor unit with a press-button user interface, and 1 expression kit (Cushion-type) with 1 milk collection container. With a rechargeable battery.
Catalog Number
SCF392/61
Brand Name
Philips Avent Single electric breast pump Advanced
Version/Model Number
SCF392/61
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
K201381
Product Code
HGX
Product Code Name
Pump, Breast, Powered
Public Device Record Key
26a63551-8567-4758-9146-2a7121d18a3f
Public Version Date
December 25, 2020
Public Version Number
1
DI Record Publish Date
December 17, 2020
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |