Duns Number:048403299
Device Description: High Flow Rate Kit (2 x F275, 5 x F600, 5 x F900, 4 x F1200, 4 x F2400)
Catalog Number
H20KT
Brand Name
RMS Precision Flow Rate TubingTM
Version/Model Number
H20KT
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
Product Code
FRN
Product Code Name
Pump, infusion
Public Device Record Key
c9079736-1ac4-4c35-ab94-f62041536078
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 19, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |