Humidifier Nebulizer Kit
The Humidifier Nebulizer Kit is a convenience kit combining components for both humidification and nebulization of inhaled respiratory gases or aerosolized medications, used in anesthetic and respiratory care settings. Classified as FDA Class 2 under regulation 21 CFR 868.5450 within the Anesthesiology medical specialty, it is under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance and does not require a 510(k) submission when all criteria are met. The product code is OGG. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OGG
- Device Class
- FDA class 2
- Regulation Number
- 868.5450
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- 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 www.Fda.Gov/cdrh/ode/convkit.Html. 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 32 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 32 registration numbers. Click on an entry to view related FDA registrations.