Duns Number:002348191
Device Description: Catheter Hemostasis Valve For Use with .038" (.096 cm) dia. and smaller guide wires
Catalog Number
AI-07000
Brand Name
ARROW
Version/Model Number
IPN032604
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
1e261224-1ba2-447a-b5ba-7f4f888a7421
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
30801902097911
Quantity per Package
50
Contains DI Package
00801902097910
Package Discontinue Date
-
Package Status
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 |