Duns Number:595138793
Device Description: Single non-flushing transducer with stopcocks at either ends
Catalog Number
687276
Brand Name
PROVIDENCE SEATTLE - CATH LAB TRANSDUCER
Version/Model Number
687276
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
a8a5a0d3-40b2-483c-8178-d55ac0c1fcde
Public Version Date
June 11, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
50886333672764
Quantity per Package
100
Contains DI Package
00886333672769
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 |