Duns Number:344267187
Device Description: Single-Use Tubing Set for joimax® Multi-Range Irrigation Pump JIFP2000
Catalog Number
-
Brand Name
Versicon®
Version/Model Number
JTSB300D
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
-
Product Code
FQH
Product Code Name
Lavage, Jet
Public Device Record Key
598d05e8-ab2b-4cb5-8cbc-39b446938f11
Public Version Date
April 23, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
04250337103202
Quantity per Package
10
Contains DI Package
04250337100812
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 293 |