Duns Number:502960539
Device Description: The powered breast pump is intended to express and collect the breast milkof a nursing wom The powered breast pump is intended to express and collect the breast milkof a nursing womanfor the purpose of feeding the collected milk to baby
Catalog Number
P53149-01
Brand Name
Lansinoh Smart Pump Base Only
Version/Model Number
DEBP 2.2
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
4b574e9a-a3f4-4157-971e-32d951f8f0c9
Public Version Date
April 02, 2018
Public Version Number
1
DI Record Publish Date
March 01, 2018
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. | 9 |