Duns Number:052002029
Device Description: Breast pump kit
Catalog Number
-
Brand Name
Symphony & Lactina Breast pump kit
Version/Model Number
67206
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OHH
Product Code Name
Breast Pump Kit
Public Device Record Key
6ad88410-875c-479b-9604-a00d61410b92
Public Version Date
April 25, 2018
Public Version Number
3
DI Record Publish Date
December 12, 2016
Package DI Number
20020451672063
Quantity per Package
3
Contains DI Package
00020451672069
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 244 |