Duns Number:002348191
Device Description: FlexBlock(R) Continuous Peripheral Nerve Block Kit
Catalog Number
FB-19608-KU
Brand Name
ARROW
Version/Model Number
IPN046020
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
-
Product Code
CAZ
Product Code Name
Anesthesia conduction kit
Public Device Record Key
122f6f11-6e50-4c20-9f07-2f2d90bb2d49
Public Version Date
May 27, 2022
Public Version Number
2
DI Record Publish Date
September 29, 2021
Package DI Number
80801902114491
Quantity per Package
5
Contains DI Package
70801902114494
Package Discontinue Date
May 23, 2022
Package Status
Not in Commercial Distribution
Package Type
Case
| 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 |