Duns Number:830201237
Catalog Number
91002634
Brand Name
NUK® Double Electric Breast Pump
Version/Model Number
62601
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HGX
Product Code Name
Pump, Breast, Powered
Public Device Record Key
8f67244b-bfc7-493f-9e53-4de10c90886a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 29, 2016
Package DI Number
10885131626018
Quantity per Package
2
Contains DI Package
00885131626011
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Corrugate Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 2 |