Duns Number:240992693
Device Description: 20 ML ORAL SYRINGE
Catalog Number
YM54-5120
Brand Name
MED-RX
Version/Model Number
YM54-5120
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)
Yes
Over the Counter (OTC)
-
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
0032a2a4-4de6-40ff-b5ac-30a1db3f5e34
Public Version Date
October 29, 2021
Public Version Number
5
DI Record Publish Date
October 30, 2018
Package DI Number
50628725005251
Quantity per Package
100
Contains DI Package
00628725005256
Package Discontinue Date
-
Package Status
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 | 19 |
2 | A medical device with a moderate to high risk that requires special controls. | 15 |