Duns Number:052002029
Device Description: 3mL Non-Sterile Enteral/Oral Syringe with ENFit Low Dose Tip
Catalog Number
-
Brand Name
Enteral Feeding
Version/Model Number
101034138
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K162188,K162188,K162188,K162188
Product Code
PNR
Product Code Name
Enteral Syringes With Enteral Specific Connectors
Public Device Record Key
7784b846-ca8b-4b7a-b663-ccf2a36ba9cd
Public Version Date
October 29, 2021
Public Version Number
7
DI Record Publish Date
July 28, 2017
Package DI Number
30020451330946
Quantity per Package
6
Contains DI Package
20020451330949
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 244 |