Duns Number:481670396
Device Description: The Ardo Pumpset should be used in combination with Ardo breastpumps and is intended to be The Ardo Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating womento express and collect milk from their breast. The Pumpset can be used both as a single pumpset and as a double pumpset and is intented for single users only.
Catalog Number
63.00.219
Brand Name
Single Pumpset
Version/Model Number
63.00.219
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
630dafbe-4162-4938-b1b8-f13db653c16c
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 12, 2019
Package DI Number
00814079021459
Quantity per Package
12
Contains DI Package
00814079021442
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 |