Duns Number:079375431
Device Description: Enteral Syringe with ENFit® Connector, 60mL
Catalog Number
SYR-60S
Brand Name
AVANOS
Version/Model Number
47069
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
PNR
Product Code Name
Enteral Syringes with enteral specific connectors
Public Device Record Key
96f6ff5a-4dde-4f63-a959-ac47de7f7639
Public Version Date
May 31, 2019
Public Version Number
1
DI Record Publish Date
May 23, 2019
Package DI Number
10350770470693
Quantity per Package
50
Contains DI Package
00350770470696
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
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 |