Duns Number:080521145
Device Description: Double Breast Pump_Blue
Catalog Number
-
Brand Name
Little Martin's Drawer
Version/Model Number
BBP1705
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
K163136
Product Code
HGX
Product Code Name
Pump, Breast, Powered
Public Device Record Key
b641d448-e0db-43c0-ab08-46950394aae2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 28, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 8 |