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 9 Plus
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
K162415,K162415,K162415,K162415,K162415
Product Code
HGX
Product Code Name
Pump, Breast, Powered
Public Device Record Key
d1439ec9-a606-4dfd-8aa6-e9949f7d39d1
Public Version Date
March 17, 2021
Public Version Number
4
DI Record Publish Date
May 30, 2017
Package DI Number
28809108011354
Quantity per Package
8
Contains DI Package
18809108011357
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton 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 |