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 Handy Plus
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
18e42573-2294-4436-b320-93a31d6f9e68
Public Version Date
March 17, 2021
Public Version Number
3
DI Record Publish Date
March 06, 2017
Package DI Number
28809108012573
Quantity per Package
30
Contains DI Package
08809108012760
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 |