Duns Number:545570186
Device Description: The ENFit® Reusable Enteral Syringe is indicated for use as a dispenser, a measuring devic The ENFit® Reusable Enteral Syringe is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used multiple times in non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only.
Catalog Number
-
Brand Name
Wealy
Version/Model Number
60ml
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K203613,K203613,K203613
Product Code
KCP
Product Code Name
Syringe, Ent
Public Device Record Key
4b39233b-5300-49e1-8a90-d5c2ea84647e
Public Version Date
October 21, 2022
Public Version Number
1
DI Record Publish Date
October 13, 2022
Package DI Number
06971603585239
Quantity per Package
60
Contains DI Package
06971603585222
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box