Duns Number:928308407
Device Description: K-Pump Infiltration Device. Surgical Infiltration/ Irrigation pump. Vibration free, quiet K-Pump Infiltration Device. Surgical Infiltration/ Irrigation pump. Vibration free, quiet K-Pump is capable of infiltration rate from 20-1020 ml/ min. The K-Pump is controlled by pneumatic footswitch.
Catalog Number
IM-1000-0031
Brand Name
K-Pump
Version/Model Number
1000-0031
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
-
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
K991203
Product Code
FRN
Product Code Name
Pump, Infusion
Public Device Record Key
7cc851f5-9aaf-4dec-b760-9c98be4c049a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 12, 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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |