Last synced on 9 May 2025 at 11:05 pm

Cap, Device Disinfectant

Page Type
Product Code
Definition
Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time
Physical State
A molded cap with a disinfectant pad to fit on a luer access device
Technical Method
Fits on a Luer Access Valve to disinfect the valve, then act as physical barrier to contamination
Target Area
Intravascular
Review Panel
General Hospital
Submission Type
510(K)
Device Classification
U
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code QBP is assigned to devices that are "unclassified" (e.g. pre-amendment), it is not linked to any specific regulation and CFR section.

Cap, Device Disinfectant

Page Type
Product Code
Definition
Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time
Physical State
A molded cap with a disinfectant pad to fit on a luer access device
Technical Method
Fits on a Luer Access Valve to disinfect the valve, then act as physical barrier to contamination
Target Area
Intravascular
Review Panel
General Hospital
Submission Type
510(K)
Device Classification
U
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code QBP is assigned to devices that are "unclassified" (e.g. pre-amendment), it is not linked to any specific regulation and CFR section.