Duns Number:002348191
Device Description: Epidural Catheterization Kit with FlexTip Plus(R) Catheter FOR EXPORT ONLY
Catalog Number
ASK-05500-KM
Brand Name
ARROW
Version/Model Number
IPN042606
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
-
Product Code
OGE
Product Code Name
Epidural anesthesia kit
Public Device Record Key
8b5575cf-bf38-47ba-a039-25f33a0bfb18
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
October 26, 2016
Package DI Number
20801902128151
Quantity per Package
5
Contains DI Package
10801902128154
Package Discontinue Date
February 23, 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 |