Duns Number:595138793
Device Description: A non flushing transducer, 36" Male/Male Pressure Tubing and 2 x 4-Way stopcocks. A separa A non flushing transducer, 36" Male/Male Pressure Tubing and 2 x 4-Way stopcocks. A separately packed 2x male protective caps.
Catalog Number
688694
Brand Name
PRESSURE MONITORING SET
Version/Model Number
688694
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
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
ca4a447d-3643-4da2-8dfb-bd9b69590700
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
50886333686945
Quantity per Package
50
Contains DI Package
00886333686940
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Tyvek Pouch
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 392 |