Duns Number:025460908
Device Description: ARTERIAL LINE ADD - A CATH TRA
Catalog Number
ARTNC120
Brand Name
Centurion Medical Products Corp
Version/Model Number
ARTNC120
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
OFF
Product Code Name
Central venous catheter tray
Public Device Record Key
95c9ff1d-601e-4551-bd10-f15758d8d0e6
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
May 29, 2022
Package DI Number
40653160993163
Quantity per Package
15
Contains DI Package
10653160993162
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |