Duns Number:097736867
Device Description: 5F x 10cm Jet-Vac Centesis Catheter
Catalog Number
M7514
Brand Name
Jet-Vac Procedure Trays
Version/Model Number
M7514
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"
Yes
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
GCB
Product Code Name
Needle, Catheter
Public Device Record Key
fa8ddfa9-7581-4449-b3d1-ddadee673a2c
Public Version Date
September 06, 2019
Public Version Number
3
DI Record Publish Date
October 02, 2016
Package DI Number
20813623015535
Quantity per Package
20
Contains DI Package
10813623015538
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 | 25 |
2 | A medical device with a moderate to high risk that requires special controls. | 109 |