Duns Number:757634266
Catalog Number
FCT50-60m-BRAUN
Brand Name
Flow Control Tubing
Version/Model Number
FCT 50mL/60mins
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
K910007,K910007,K910007
Product Code
FRN
Product Code Name
Pump, Infusion
Public Device Record Key
f1cabcf2-f311-499a-aac0-b30346c68960
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 03, 2016
Package DI Number
9350902001539
Quantity per Package
840
Contains DI Package
09350902001515
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 5 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |