Duns Number:052002029
Device Description: Enteral Syringe 10 mL, Bonded TwistLok Connector
Catalog Number
-
Brand Name
Enteral Feeding
Version/Model Number
TLINT10
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)
-
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
7b935be6-0cd9-4864-8c19-078c1c35f836
Public Version Date
October 29, 2021
Public Version Number
7
DI Record Publish Date
December 20, 2017
Package DI Number
20020451331595
Quantity per Package
100
Contains DI Package
00020451331591
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 |