Duns Number:068586441
Device Description: Cup Medicine 1 oz 100/Pack
Catalog Number
781031
Brand Name
Dealmed
Version/Model Number
817415021318
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KYW
Product Code Name
CONTAINER, LIQUID MEDICATION, GRADUATED
Public Device Record Key
7dbdd9dc-2ee8-445c-863e-aef9a786de5c
Public Version Date
October 30, 2020
Public Version Number
1
DI Record Publish Date
October 22, 2020
Package DI Number
10817415021318
Quantity per Package
50
Contains DI Package
00817415021311
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 | 37 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |