Duns Number:079375431
Device Description: AVANOS* Enteral Low Dose Tip Syringe with ENFit® Compatible Connector-Sterile
Catalog Number
SYR-05S
Brand Name
AVANOS*
Version/Model Number
SYR-05S
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
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
PNR
Product Code Name
Enteral Syringes with enteral specific connectors
Public Device Record Key
63504cef-9a59-42e8-9e9b-3a0b93ae48c1
Public Version Date
February 04, 2021
Public Version Number
1
DI Record Publish Date
January 27, 2021
Package DI Number
10350770470723
Quantity per Package
100
Contains DI Package
00350770470726
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
DSP
| 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 |