Duns Number:038000253
Device Description: 14GA X 20CM SINGLE LUMEN INFUSION CATHETER SET
Catalog Number
-
Brand Name
Infusion Catheters
Version/Model Number
CSP-1408
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 02, 2021
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
DQO
Product Code Name
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Public Device Record Key
0185529c-6e35-4ab9-8b1f-9465119c1d50
Public Version Date
August 03, 2021
Public Version Number
7
DI Record Publish Date
November 17, 2015
Package DI Number
50884908007393
Quantity per Package
20
Contains DI Package
00884908007398
Package Discontinue Date
August 02, 2021
Package Status
Not 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 | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2560 |