Duns Number:106885259
Device Description: Klein Touch Pump
Catalog Number
KTP
Brand Name
Klein Touch Pump
Version/Model Number
KTP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 10, 2020
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K123822
Product Code
FRN
Product Code Name
Pump, Infusion
Public Device Record Key
bb6fdeaf-24fc-401d-8198-f4dcd4f3990c
Public Version Date
July 04, 2022
Public Version Number
6
DI Record Publish Date
September 21, 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 | 77 |
2 | A medical device with a moderate to high risk that requires special controls. | 12 |