Duns Number:481670396
Device Description: The One Mum Pumpset should be used in combination with Ardo breastpumps and is intended to The One Mum Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express and collect milk from their breast. The One Mum Pumpset can be used both as a single pumpset and as a double pumpset and is intended for single users only.
Catalog Number
63.00.114
Brand Name
OneMumPumpset D26
Version/Model Number
63.00.114
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
K172067,K172067
Product Code
HGX
Product Code Name
Pump, Breast, Powered
Public Device Record Key
7dfd70b3-46b8-4f1e-b64f-54b4d05e980f
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
March 01, 2018
Package DI Number
00814079021541
Quantity per Package
30
Contains DI Package
00814079021534
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 |