Duns Number:002348191
Device Description: ARROW® Epidural Catheterization Set with FlexTip Plus(R), Closed Tip Multi-Port Catheter
Catalog Number
MP-17019-TIG
Brand Name
ARROW
Version/Model Number
IPN040178
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"
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
-
Product Code
CAZ
Product Code Name
Anesthesia conduction kit
Public Device Record Key
83e232a7-b587-4c03-91d0-14ad236c5fb7
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
30801902070174
Quantity per Package
5
Contains DI Package
00801902070173
Package Discontinue Date
July 07, 2017
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 |