Duns Number:481670396
Device Description: Easy Freeze breast milk bags for safe and space-saving storage of breast milk in your frid Easy Freeze breast milk bags for safe and space-saving storage of breast milk in your fridge or freezer.
Catalog Number
63.00.207
Brand Name
Easy Freeze
Version/Model Number
63.00.207
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
K141742,K141742,K141742
Product Code
HGX
Product Code Name
Pump, Breast, Powered
Public Device Record Key
e9eb1112-2906-4699-b1e2-01904cc5b117
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 30, 2016
Package DI Number
00814079020223
Quantity per Package
18
Contains DI Package
00814079020216
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |