Duns Number:688451947
Device Description: This is placed in the bra, allowing moms to express breastmilk hands free.It is connected This is placed in the bra, allowing moms to express breastmilk hands free.It is connected to backdraft prevention unit (cap), pressure adjustment unit (silicon head) and bottle when used.
Catalog Number
-
Brand Name
Spectra
Version/Model Number
Spectra accessory (28mm Care Cup)
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
HGX
Product Code Name
Pump, Breast, Powered
Public Device Record Key
986c125b-5adc-4efd-aea6-2cb17e3af7ce
Public Version Date
March 17, 2021
Public Version Number
1
DI Record Publish Date
March 09, 2021
Package DI Number
28809108013761
Quantity per Package
8
Contains DI Package
08809108013767
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 |