Duns Number:481670396
Device Description: The Calypso breast pump is intended to be used by lactating women to express and collect m The Calypso breast pump is intended to be used by lactating women to express and collect milk from their breast.It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for single users.The package also contains an adapter for manual pumping as well as spare parts for the pumpset.
Catalog Number
63.00.320
Brand Name
Calypso Essentials TX
Version/Model Number
63.00.320
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
K141742
Product Code
HGX
Product Code Name
Pump, Breast, Powered
Public Device Record Key
b8c8f2c5-edf9-4d54-aadb-617bb061220b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 23, 2017
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |