Duns Number:079290879
Device Description: The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGU The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology
Catalog Number
96001
Brand Name
ARTERIAL WAND
Version/Model Number
3Fr x 5cm
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"
Yes
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
K181563,K181563,K181563
Product Code
DQY
Product Code Name
Catheter, Percutaneous
Public Device Record Key
20dd937d-639a-4b97-8d14-05129c601527
Public Version Date
November 12, 2018
Public Version Number
1
DI Record Publish Date
October 11, 2018
Package DI Number
20859821006692
Quantity per Package
12
Contains DI Package
10859821006695
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 59 |