Parenteral Administration Kit
The Parenteral Administration Kit (product code POR) is a Class 2 general hospital convenience kit established in accordance with the May 1997 Convenience Kits Interim Regulatory Guidance, regulated under 880.5440. Under enforcement discretion, the kit does not require a 510(k) to market as long as it meets all criteria in the guidance. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- POR
- Device Class
- FDA class 2
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 7
Device Characteristics
Definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm . This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
FEI Numbers
This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.