Duns Number:502960539
Device Description: It is used for baby feeding.
Catalog Number
-
Brand Name
Lansinoh 8oz Bottle with NaturalWave Nipple
Version/Model Number
P71055-00
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
716e383d-8bd5-4288-bc2f-6834fadaf37d
Public Version Date
October 29, 2018
Public Version Number
1
DI Record Publish Date
September 27, 2018
Package DI Number
10044677710555
Quantity per Package
12
Contains DI Package
00044677710558
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 9 |