Duns Number:689908411
Device Description: The Duo Double Electric Breast Pump is a single user, double electric breast pump that inc The Duo Double Electric Breast Pump is a single user, double electric breast pump that includes customizable massage and expression modes and is capable of single and double pumping.
Catalog Number
-
Brand Name
Duo Double Electric Breast Pump
Version/Model Number
AAA0021
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K160274,K160274,K160274,K160274,K160274
Product Code
HGX
Product Code Name
Pump, Breast, Powered
Public Device Record Key
01769e84-842e-4be0-a4d8-2efec9246419
Public Version Date
November 05, 2021
Public Version Number
1
DI Record Publish Date
October 28, 2021
Package DI Number
00887529000472
Quantity per Package
1
Contains DI Package
00887529000465
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Gift Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |