Duns Number:022760922
Device Description: Enteral Only 3ml Syringe with Oral Cap
Catalog Number
-
Brand Name
NC600300
Version/Model Number
NC600300
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K103830,K103830,K103830,K103830
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
08c94808-4d4c-4a52-b48b-0a5ff95b4962
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
March 01, 2019
Package DI Number
20816336022067
Quantity per Package
200
Contains DI Package
10816336022060
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 112 |