Duns Number:502960539
Device Description: The Powered Breast Pump is intended to express and collect the breast milk of a nursing wo The Powered Breast Pump is intended to express and collect the breast milk of a nursing woman for the purpose of feeding the collected milk to a baby.
Catalog Number
53116
Brand Name
Lansinoh Smart Pump - DME
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
4d60194d-87f8-4a21-a68e-5f9c51de278f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 05, 2017
Package DI Number
60044677531162
Quantity per Package
1
Contains DI Package
00044677531160
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. | 9 |