Duns Number:595138793
Device Description: A single 3cc transducer connected to a 20 drops, 60" tube AdSet. patient line is connected A single 3cc transducer connected to a 20 drops, 60" tube AdSet. patient line is connected to a 12" Pressure Tube and a 72" Pressure tube via 3-way stopcock. It also includes a separately packed 3xmale & 1x Female fittings protective caps and a Label Set.
Catalog Number
686973
Brand Name
JEWISH HOSPITAL-SINGLE ARTERIAL LINE
Version/Model Number
686973
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
6a704cef-b843-440d-af40-20a47a3e31fc
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 22, 2016
Package DI Number
50886333669733
Quantity per Package
25
Contains DI Package
00886333669738
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 |