Duns Number:079527070
Device Description: 1 mL ENFit Low Dose Tip Syringe
Catalog Number
VED-601EO
Brand Name
Vesco Medical ENFit Low Dose Tip Syringe
Version/Model Number
VED-601EO
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
K161979,K161979,K161979
Product Code
PNR
Product Code Name
Enteral Syringes With Enteral Specific Connectors
Public Device Record Key
a2b5d79b-3c98-4944-8465-8c7f479bdcf0
Public Version Date
October 29, 2021
Public Version Number
7
DI Record Publish Date
October 05, 2017
Package DI Number
20850801006381
Quantity per Package
4
Contains DI Package
10850801006384
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 8 |