Duns Number:489122720
Device Description: The Philips Avent Manual Breast Pump consists of:- a pump handle which is squeezed by the The Philips Avent Manual Breast Pump consists of:- a pump handle which is squeezed by the user to suction milk from the breast- a breast shield wich is centered over the nipple - a milk container which collect the milk as it is pumped from the breast The Philips Avent Manual Breast Pump is intended to express and collect milk from the breast of a lactating woman. The device is intended for a single user.
Catalog Number
SCF430/30
Brand Name
Philips Avent Manual Breast Pump
Version/Model Number
SCF430/30
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
HGY
Product Code Name
Pump, Breast, Non-Powered
Public Device Record Key
a1210066-d0f3-4eca-9cf6-d3ca5ea341d2
Public Version Date
July 12, 2021
Public Version Number
1
DI Record Publish Date
July 02, 2021
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 |