Duns Number:595138793
Device Description: 1-way 20 drops, 60" Adset connected with a 3cc Transducer. The blood sampling line has a 2 1-way 20 drops, 60" Adset connected with a 3cc Transducer. The blood sampling line has a 24" Small Bore tube , a 1-way stopcock and another 6" small bore tube connect to the Septum Device. The other end of the device connects to a 3-way Red and a 3-way White stopcocks , a 6" Pressure Tubing which cis connected to a 5cc Restricted Syringe with touchguard stops at 3cc.
Catalog Number
688075
Brand Name
PROVIDENCE HOSPITAL - ONE LINE SET
Version/Model Number
688075
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
b1434ee9-9bbd-498b-972a-cdecbeec9fd4
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
50886333680752
Quantity per Package
25
Contains DI Package
00886333680757
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 |