Duns Number:595138793
Device Description: A Dome, Male/Male 36" Pressure Tubing and 2 x 4-Way stopcocks. A separately packed male pr A Dome, Male/Male 36" Pressure Tubing and 2 x 4-Way stopcocks. A separately packed male protective caps.
Catalog Number
688737
Brand Name
PRESSURE MONITORING DOME SET
Version/Model Number
688737
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
DXO
Product Code Name
Transducer, Pressure, Catheter Tip
Public Device Record Key
6d41fc80-9000-44c5-9794-b467adb79f9c
Public Version Date
June 11, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
50886333687379
Quantity per Package
100
Contains DI Package
00886333687374
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Tyvek Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 392 |