Duns Number:545287658
Device Description: SJ-2500 is the suction jar which is used to collect pus, blood clots, phlegm, and excess f SJ-2500 is the suction jar which is used to collect pus, blood clots, phlegm, and excess fluids by connecting to a patient on one end, and vacuum source (such as suction regulator) on the other
Catalog Number
-
Brand Name
GENTEC®
Version/Model Number
SJ-2500
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
November 09, 2031
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KDQ
Product Code Name
Bottle, Collection, Vacuum
Public Device Record Key
6b095f82-96b6-4275-bd9d-b34f07c9de54
Public Version Date
November 17, 2021
Public Version Number
1
DI Record Publish Date
November 09, 2021
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 | 34 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |