Duns Number:033337813
Device Description: Premium Breastfeeding Pump
Catalog Number
-
Brand Name
Nature's Bond
Version/Model Number
603
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K142168,K142168
Product Code
HGX
Product Code Name
Pump, Breast, Powered
Public Device Record Key
c6835c0b-20fa-4e48-924d-c9fe60c08766
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 31, 2016
Package DI Number
10879766003597
Quantity per Package
2
Contains DI Package
00879766003590
Package Discontinue Date
-
Package Status
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. | 64 |