Duns Number:867673159
Device Description: Personal CareBreast Pump Product Description: Single Automatic Breast Pump 1/ea
Catalog Number
-
Brand Name
Medquip
Version/Model Number
MQ9000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 21, 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
K113315,K113315
Product Code
HGX
Product Code Name
PUMP, BREAST, POWERED
Public Device Record Key
c7c811c2-bf28-4e3b-8174-ca9a37c07632
Public Version Date
June 02, 2020
Public Version Number
2
DI Record Publish Date
June 21, 2019
Package DI Number
50718122644396
Quantity per Package
6
Contains DI Package
00718122644391
Package Discontinue Date
June 21, 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 |