Duns Number:002348191
Device Description: Epidural Catheterization Kit with FlexTip Plus(R) Catheter
Catalog Number
ASK-05502-MC
Brand Name
ARROW
Version/Model Number
IPN045699
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"
-
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
56d0d42c-0bb6-43ee-a9a8-05af6b466c54
Public Version Date
February 07, 2019
Public Version Number
6
DI Record Publish Date
September 16, 2016
Package DI Number
30801902068348
Quantity per Package
5
Contains DI Package
00801902068347
Package Discontinue Date
July 20, 2018
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 |