Duns Number:052002029
Device Description: Enteral Syringe 60mL, Bonded Slip Tip Connector
Catalog Number
-
Brand Name
Enteral Feeding
Version/Model Number
INT60
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 14, 2018
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
K894206,K894206
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
9a4f142d-0c90-428b-9b77-d2e25b45b900
Public Version Date
October 29, 2021
Public Version Number
8
DI Record Publish Date
December 20, 2017
Package DI Number
20020451331366
Quantity per Package
50
Contains DI Package
00020451331362
Package Discontinue Date
August 14, 2018
Package Status
Not 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 |