Duns Number:239403863
Device Description: The re-usable Irrigation pump is a pneumatically operated device that has been designed to
Catalog Number
PS3871
Brand Name
Dual chamber irrigation pump reusable
Version/Model Number
PS3871
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
-
Product Code
KZD
Product Code Name
Infusor, Pressure, For I.V. Bags
Public Device Record Key
4edb97a7-2316-4c95-b182-a0d674b40387
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 18, 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 | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 128 |