Enteral Administration Kit (Adult & Pediatric)
The Enteral Administration Kit (Adult and Pediatric) is a convenience kit containing supplies used for enteral nutrition administration in both adult and pediatric patients who require tube feeding in the Gastroenterology and Urology specialty. It is classified as FDA Class 2 under 21 CFR 876.5980. Per the FDA's 1997 Convenience Kits Interim Regulatory Guidance, this kit is under enforcement discretion and does not require a 510(k) premarket notification if it meets all applicable criteria. Product code PRM; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PRM
- Device Class
- FDA class 2
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
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/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.