Duns Number:657267337
Device Description: Maymom breast flange set made for Motif Medical containing two 27mm flanges compatible wit Maymom breast flange set made for Motif Medical containing two 27mm flanges compatible with Medela pumps, two valves, two membranes.
Catalog Number
mtf_M012-LFx2
Brand Name
Maymom Double Flange Set for Medela Pump in Style Advanced Pump, 27 mm
Version/Model Number
mtf_M012-LFx2
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
OHH
Product Code Name
Breast Pump Kit
Public Device Record Key
741a0fe8-6b69-42e4-84b3-f30789dbddfc
Public Version Date
May 11, 2020
Public Version Number
1
DI Record Publish Date
May 01, 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. | 8 |