Duns Number:481670396
Device Description: The Calypso Pro Electrical Breast Pump is intended to be used by lactating women to expres The Calypso Pro Electrical Breast Pump is intended to be used by lactating women to express and collect milk from theis breast.It can be used as a single and as double pump. The unit is intended for indoor use only and is intended for multiple users.
Catalog Number
63.00.336
Brand Name
Calypso Pro Complete
Version/Model Number
63.00.336
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
K150721,K150721
Product Code
HGX
Product Code Name
Pump, Breast, Powered
Public Device Record Key
1ccee2dc-0779-47ed-b451-26083c53805f
Public Version Date
October 25, 2018
Public Version Number
1
DI Record Publish Date
September 24, 2018
Package DI Number
00814079022029
Quantity per Package
80
Contains DI Package
00814079021992
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pallet
| 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. | 15 |