Duns Number:048403299
Device Description: Flow Control Infusion Tubing
Catalog Number
F15
Brand Name
RMS Precision Flow Rate TubingTM
Version/Model Number
F15
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K933652,K933652
Product Code
FRN
Product Code Name
Pump, infusion
Public Device Record Key
3d62f954-cd8d-4aaa-bee8-6925bba22cf5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 19, 2016
Package DI Number
10659443000107
Quantity per Package
50
Contains DI Package
00659443000100
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 201 |
2 | A medical device with a moderate to high risk that requires special controls. | 99 |