Duns Number:065183758
Device Description: Quiet Expressions breast pump with Breastflow bottle
Catalog Number
-
Brand Name
The First Years
Version/Model Number
Y6228
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
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
05f55bff-9c27-4f31-a72d-2ce7255a66b1
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 11, 2017
Package DI Number
B268Y62281
Quantity per Package
1
Contains DI Package
B268Y62280
Package Discontinue Date
-
Package Status
-
Package Type
Retail Pkg
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 10 |