Duns Number:867673159
Device Description: Personal CareBreast Pump Product Description: Deluxe Double Electric Breast Pump 1/ea
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
RTLBP2200
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 01, 2019
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
9d2c9f53-59ab-4451-883f-39ff40a95ce5
Public Version Date
July 16, 2019
Public Version Number
2
DI Record Publish Date
November 16, 2018
Package DI Number
50822383972270
Quantity per Package
4
Contains DI Package
00822383972275
Package Discontinue Date
January 01, 2019
Package Status
Not 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 |