Duns Number:116981210
Device Description: Indwell Slit Catheter Set (12/pkg). Each set includes slit catheter, breakaway needle and Indwell Slit Catheter Set (12/pkg). Each set includes slit catheter, breakaway needle and extension tubing.
Catalog Number
-
Brand Name
Indwelling Slit Catheter
Version/Model Number
0295-006-000
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
K844214,K844214
Product Code
LXC
Product Code Name
Monitor, Pressure, Intracompartmental
Public Device Record Key
3e8bd904-d1f1-4a40-998a-02f6e4e65bc8
Public Version Date
May 10, 2021
Public Version Number
2
DI Record Publish Date
April 08, 2020
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| U | Unclassified | 8 |