Duns Number:801895244
Device Description: Fiberoptic Pressure Transducer Catheter: Abdominal, 10 French
Catalog Number
-
Brand Name
Lumax TS Pro
Version/Model Number
10307-009
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
K953734,K953734
Product Code
FEN
Product Code Name
Device, Cystometric, Hydraulic
Public Device Record Key
1036d5cd-3289-495b-bb13-b62c049a1ed7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 09, 2016
Package DI Number
20888937011160
Quantity per Package
10
Contains DI Package
00888937011166
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |