Duns Number:481670396
Device Description: Device for pumping and collecting breast milk . The Ardo Pumpset should be used in combina Device for pumping and collecting breast milk . The Ardo Pumpset should be used in combination with Ardo breastpumps and is intended for the expression, collection and storage of breast milk. The pumpset can be used as a single or double pumpset.
Catalog Number
63.00.337
Brand Name
Double Pumping Collection Kit
Version/Model Number
63.00.337
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,K141742
Product Code
HGX
Product Code Name
Pump, Breast, Powered
Public Device Record Key
67e03e30-ec60-4d92-bc90-df76add50721
Public Version Date
October 25, 2018
Public Version Number
1
DI Record Publish Date
September 24, 2018
Package DI Number
00814079022012
Quantity per Package
25
Contains DI Package
00814079022005
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
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. | 15 |