Duns Number:688451947
Device Description: A hand-held device used to extract milk from the breast, typically for collecting and feed A hand-held device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a low-grade suction through a funnel-like component that is applied to the breast and is typically operated by the donor; the milk collects in an attached vessel (e.g., a sterilized bottle). This is a reusable device.
Catalog Number
-
Brand Name
Spectra
Version/Model Number
Spectra accessory (Accessory Kit_Manual switch)
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
HGY
Product Code Name
Pump, Breast, Non-Powered
Public Device Record Key
dc352ef9-e7bf-4225-a18a-649d9a8213b1
Public Version Date
March 17, 2021
Public Version Number
2
DI Record Publish Date
October 19, 2019
Package DI Number
28809108011583
Quantity per Package
300
Contains DI Package
08809108017550
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 |