Duns Number:052002029
Device Description: Breast pump kit
Catalog Number
-
Brand Name
Symphony Breast Milk Initiation Kit – Non Sterile
Version/Model Number
101041821
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"
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
c546da16-8e9b-460f-b2d3-c4989526e3d7
Public Version Date
November 09, 2020
Public Version Number
1
DI Record Publish Date
October 30, 2020
Package DI Number
20020451418210
Quantity per Package
10
Contains DI Package
00020451418216
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 244 |