Duns Number:022760922
Device Description: Enteral Only 12ml Syringe with Oral Cap
Catalog Number
-
Brand Name
NC601200
Version/Model Number
NC601200
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
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
b504bd27-5d97-400e-812a-54dc074a1aab
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
August 18, 2021
Package DI Number
20816336022227
Quantity per Package
100
Contains DI Package
10816336022220
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 |