Duns Number:079375431
Device Description: Enteral Low Dose Tip Syringe with ENFit® Compatible Connector, 10mL
Catalog Number
SYR-10NS
Brand Name
AVANOS
Version/Model Number
47109
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PNR
Product Code Name
Enteral Syringes with enteral specific connectors
Public Device Record Key
b791723d-b11f-4c04-bb3d-b12f959e99b2
Public Version Date
May 31, 2019
Public Version Number
1
DI Record Publish Date
May 23, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 269 |
2 | A medical device with a moderate to high risk that requires special controls. | 5221 |