Duns Number:867673159
Device Description: Personal CareBreast Pump Product Description: Double Electric Breast Pump,1/EA
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
RTLBP0200
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
K132882,K132882
Product Code
HGX
Product Code Name
PUMP, BREAST, POWERED
Public Device Record Key
bbc2b84a-78f4-45b6-aa67-ec5c4118d3c2
Public Version Date
July 01, 2019
Public Version Number
1
DI Record Publish Date
June 21, 2019
Package DI Number
50822383975592
Quantity per Package
4
Contains DI Package
00822383975597
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |