Duns Number:027680821
Device Description: Intended to provide security and patient comfort by firmly holding tubing in place
Catalog Number
-
Brand Name
Secure-It ™ Catheter Tube Holder
Version/Model Number
630010XBX
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGX
Product Code Name
Tape and bandage, adhesive
Public Device Record Key
8160f732-1508-47f5-80d8-f5dc7ed66ad8
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
February 25, 2021
Package DI Number
00840113224968
Quantity per Package
100
Contains DI Package
00840113224975
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 952 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 494 |