Duns Number:002348191
Device Description: FlexTip Plus(R) Epidural Catheterization Kit
Catalog Number
JC-05400-B
Brand Name
ARROW
Version/Model Number
IPN046311
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K103658,K103658
Product Code
CAZ
Product Code Name
Anesthesia conduction kit
Public Device Record Key
b4df52ee-4105-4a8e-b811-c912ef8f1277
Public Version Date
June 24, 2020
Public Version Number
10
DI Record Publish Date
February 15, 2018
Package DI Number
50801902029671
Quantity per Package
20
Contains DI Package
40801902029674
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |