Duns Number:688451947
Device Description: A collection of non-sterile items intended to be used in conjunction with a manual or elec A collection of non-sterile items intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. It typically includes various items such as funnel-like breast shields, tubing, connectors, and infant feeding bottle. This is a reusable device.
Catalog Number
-
Brand Name
Spectra
Version/Model Number
Spectra accessory (Accessory Kit for SG Premium(28mm))
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
42271574-38bf-4652-95ca-973ab5a4e11f
Public Version Date
July 20, 2021
Public Version Number
1
DI Record Publish Date
July 12, 2021
Package DI Number
28809108014430
Quantity per Package
50
Contains DI Package
08809108014436
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 |