Duns Number:689057658
Device Description: The Opera+ is multiple-user, powered breast pumps intended to help a mother, especially th The Opera+ is multiple-user, powered breast pumps intended to help a mother, especially those who have an excess of milk or have difficulty breast-feeding, extract residual milk from her breast
Catalog Number
-
Brand Name
Unimom
Version/Model Number
Opera+
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
K190810
Product Code
HGX
Product Code Name
Pump, Breast, Powered
Public Device Record Key
a7ad84a2-0bb9-452d-b62e-8b2ffb90930f
Public Version Date
November 15, 2021
Public Version Number
1
DI Record Publish Date
November 05, 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. | 15 |