Duns Number:002348191
Device Description: Continuous Peripheral Nerve Block Kit with Non-Stimulating Catheter and Needle Disposal Fe Continuous Peripheral Nerve Block Kit with Non-Stimulating Catheter and Needle Disposal Feature
Catalog Number
AB-05060-KNS
Brand Name
ARROW
Version/Model Number
IPN045580
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
-
Product Code
CAZ
Product Code Name
Anesthesia conduction kit
Public Device Record Key
afa0cf8c-2883-4bf7-b957-47076200fac2
Public Version Date
January 08, 2021
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
30801902076848
Quantity per Package
5
Contains DI Package
00801902076847
Package Discontinue Date
March 26, 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 |