Duns Number:002348191
Device Description: FlexTip Plus(R) Epidural Catheterization Kit
Catalog Number
MM-05503
Brand Name
ARROW
Version/Model Number
IPN046486
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
-
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
2bee9211-bacf-423f-ad7d-14cef6343efd
Public Version Date
May 24, 2022
Public Version Number
7
DI Record Publish Date
October 09, 2018
Package DI Number
50801902012062
Quantity per Package
10
Contains DI Package
40801902012065
Package Discontinue Date
May 20, 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 |