Duns Number:688451947
Device Description: This is powered breast pump to be used by lactating women to express and collect milk from This is powered breast pump to be used by lactating women to express and collect milk from their breasts.The final product is packed in a box with neccessary connecting parts including breast shield, head, membrane, tubing, backflow protector,bottle, and instruction for use, so the user can use the device right after receving them.
Catalog Number
-
Brand Name
Spectra
Version/Model Number
Spectra Synergy Gold
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
K191208,K191208,K191208
Product Code
HGX
Product Code Name
Pump, Breast, Powered
Public Device Record Key
85f31a87-661d-46c8-9b1e-99bb2faa6e33
Public Version Date
March 17, 2021
Public Version Number
3
DI Record Publish Date
April 30, 2020
Package DI Number
18809108011364
Quantity per Package
1
Contains DI Package
08809108013439
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
design box
| 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. | 16 |