Duns Number:799772079
Device Description: 2oz Colostrum and Breastmilk Container with Transfer Lid
Catalog Number
SC-2EO
Brand Name
NeoMed Container with Transfer Lid
Version/Model Number
SC-2EO
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"
Yes
For Single-Use
Yes
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
KYX
Product Code Name
Dispenser, Liquid Medication
Public Device Record Key
bff1b6ca-6b64-47ea-b6d5-d45a897e244e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 08, 2017
Package DI Number
10817584013138
Quantity per Package
40
Contains DI Package
00817584013131
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 23 |
2 | A medical device with a moderate to high risk that requires special controls. | 183 |