Duns Number:022187754
Catalog Number
-
Brand Name
NUK Co-branded Liberty Pump
Version/Model Number
FG078
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2020
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"
Yes
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
K172772,K172772
Product Code
HGX
Product Code Name
Pump, Breast, Powered
Public Device Record Key
8786f32d-4fc8-4492-a672-60053282510a
Public Version Date
August 31, 2021
Public Version Number
4
DI Record Publish Date
October 26, 2017
Package DI Number
10885131690880
Quantity per Package
6
Contains DI Package
00885131690883
Package Discontinue Date
December 31, 2020
Package Status
Not in Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 72 |