Duns Number:595138793
Device Description: A 3-way 20 drops,60" tubing length each AdSet connected with 3x 3cc transducers at each en A 3-way 20 drops,60" tubing length each AdSet connected with 3x 3cc transducers at each end. 1 channel is connected with a septum with a 5cc syringe with touchguard stops at 2cc via a 48" & 6" Pressure Tubing & a 12" pressure Tubing from Patient. The other 2 lines connects directly to the 3cc transducer each, a 3-way stopcock and a 6" Pressure Tubing. The 3rd line has an additional 3-Way stopcock to the 6" Pressure Tubing. It includes a separately packed 4xmale & 4xfemale protective caps.
Catalog Number
687913
Brand Name
TRIPLE LINE SET WITH SAFEDRAW(TM)
Version/Model Number
687913
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
191e7480-31b0-4400-9ecc-d7638c78f9cd
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
50886333679138
Quantity per Package
20
Contains DI Package
00886333679133
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 |