Duns Number:017246562
Device Description: A-LINE INSERTION SET (FOR OR)
Catalog Number
CVI4380A
Brand Name
Centurion
Version/Model Number
CVI4380A
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CBT
Product Code Name
Arterial blood sampling kit
Public Device Record Key
5766c9e3-4d5a-431a-b3ab-b3efbbad06bc
Public Version Date
January 10, 2022
Public Version Number
1
DI Record Publish Date
January 01, 2022
Package DI Number
00653160320404
Quantity per Package
20
Contains DI Package
10653160320401
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 | 6043 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4077 |
| U | Unclassified | 1 |