Duns Number:002397347
Device Description: Introcan Safety® 18 Ga. x 2.5 in., Straight, FEP and CARESITE® Extension Set with bonded C Introcan Safety® 18 Ga. x 2.5 in., Straight, FEP and CARESITE® Extension Set with bonded CARESITE Luer Access Device, Spin-Lock® connector, 8 in. (20cm). For use with power injector
Catalog Number
375510
Brand Name
Ster-ASSIST ™
Version/Model Number
375510
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
OWL
Product Code Name
Peripheral catheter insertion kit
Public Device Record Key
7f74e892-0aa0-4e47-8e75-02288e17f4b3
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
September 23, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 277 |
| U | Unclassified | 2 |