Duns Number:002348191
Device Description: Epidural Catheterization Kit with FlexTip Plus(R), Open Tip Single-Port Catheter
Catalog Number
SM-05501
Brand Name
ARROW
Version/Model Number
IPN046641
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
K140110,K140110
Product Code
BSO
Product Code Name
CATHETER, CONDUCTION, ANESTHETIC
Public Device Record Key
903bcd57-7bbf-45bf-b8fb-a2291f54e1a2
Public Version Date
February 07, 2019
Public Version Number
3
DI Record Publish Date
July 31, 2018
Package DI Number
10801902013849
Quantity per Package
10
Contains DI Package
20801902013846
Package Discontinue Date
November 02, 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 |