Duns Number:502960539
Device Description: The Non-Powered Breast Pump is intended to express and collect the breast milk of a nursin The Non-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
50520
Brand Name
Lansinoh Manual Breast Pump
Version/Model Number
MBP 1.0
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
HGY
Product Code Name
Pump, Breast, Non-Powered
Public Device Record Key
5102df6a-b683-4313-921f-83bddb1e186b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 05, 2017
Package DI Number
60044677505200
Quantity per Package
6
Contains DI Package
20044677505202
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |