Duns Number:688451947
Device Description: This is a funnel shaped accessory, which come in contact with breat to express milk.
Catalog Number
-
Brand Name
Spectra
Version/Model Number
Spectra accessory(32mm Breast shield)
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)
Yes
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
d0c09c7e-d126-4175-ac4d-94e6abaadf24
Public Version Date
March 17, 2021
Public Version Number
3
DI Record Publish Date
March 23, 2018
Package DI Number
28809108013167
Quantity per Package
40
Contains DI Package
08809108013002
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |