Duns Number:002348191
Device Description: FlexTip Plus(R) Epidural Catheterization Kit for Caudal Placement
Catalog Number
AK-05420-P
Brand Name
ARROW
Version/Model Number
IPN045605
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
K103658,K103658
Product Code
CAZ
Product Code Name
Anesthesia conduction kit
Public Device Record Key
4c3320d4-4aab-4512-be7d-748ee29ec38f
Public Version Date
April 21, 2021
Public Version Number
5
DI Record Publish Date
September 27, 2018
Package DI Number
40801902005104
Quantity per Package
10
Contains DI Package
50801902005101
Package Discontinue Date
April 15, 2021
Package Status
Not in Commercial Distribution
Package Type
Box
| 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 |