Duns Number:002348191
Device Description: Single Shot Epidural Anesthesia Kit
Catalog Number
BH-03000-S
Brand Name
ARROW
Version/Model Number
IPN045943
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
1242e16d-79ef-4e70-a930-66dccc2b9d79
Public Version Date
July 27, 2022
Public Version Number
8
DI Record Publish Date
September 16, 2016
Package DI Number
30801902067044
Quantity per Package
5
Contains DI Package
00801902067043
Package Discontinue Date
July 22, 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 |