Label Or Tag, Non-Sterile
The Label or Tag (Non-Sterile) is a Class 1 general controls device under regulation 878.4800 in the General and Plastic Surgery specialty, intended to assist with the identification of IV infusion lines used to administer fluids and/or drug products. Clear labeling of infusion lines is a patient safety measure to prevent medication errors. Product code QMX, reviewed by the General Hospital panel. The device is not an implant, not life-sustaining, and not GMP exempt.
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Basic Information
- Product Code
- QMX
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
Definition
The device is intended to assist with identification of an IV infusion line used to administer fluids and/or drug products.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.