Duns Number:002348191
Device Description: Single Shot Epidural Anesthesia Kit
Catalog Number
AK-03000-S
Brand Name
ARROW
Version/Model Number
IPN040046
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
K770356,K770356
Product Code
CAZ
Product Code Name
Anesthesia conduction kit
Public Device Record Key
3cbde8bd-d733-4297-bbc2-c23132491c9c
Public Version Date
January 18, 2021
Public Version Number
5
DI Record Publish Date
September 27, 2018
Package DI Number
10801902067224
Quantity per Package
5
Contains DI Package
20801902067221
Package Discontinue Date
-
Package Status
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 |