Duns Number:002348191
Device Description: FlexTip Plus(R) Epidural Catheterization Kit
Catalog Number
ASK-05500-MVH
Brand Name
ARROW
Version/Model Number
IPN045678
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K140110,K140110
Product Code
BSO
Product Code Name
CATHETER, CONDUCTION, ANESTHETIC
Public Device Record Key
9b120a0d-dea3-4aa9-92d2-7d243ae95ee9
Public Version Date
June 17, 2022
Public Version Number
12
DI Record Publish Date
September 16, 2016
Package DI Number
30801902060434
Quantity per Package
10
Contains DI Package
00801902060433
Package Discontinue Date
June 13, 2022
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 |