Duns Number:689851831
Device Description: This is powered breast pump intended to express and collect milk from the breasts of lacta This is powered breast pump intended to express and collect milk from the breasts of lactating women.The final product is packed in a box with necessary connecting parts including backflow protector, tubing,valves, bottle, power adapter, flanges, locking rings, locking cap and user manual, so the user can use the device right after receiving them.
Catalog Number
-
Brand Name
Symmetrical Health, LLC
Version/Model Number
Cimilre S6
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
d013a578-c1a9-45e0-b00f-e124ed7bf67f
Public Version Date
November 15, 2021
Public Version Number
2
DI Record Publish Date
June 12, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 83 |