Oxygen Administration Kit
The Oxygen Administration Kit is a convenience kit providing components for the delivery of supplemental oxygen to patients, including masks, tubing, and related accessories used in anesthesia and respiratory care. Classified as FDA Class 2 under regulation 21 CFR 868.5655 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) when all criteria are satisfied. The product code is OGL. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OGL
- Device Class
- FDA class 2
- Regulation Number
- 868.5655
- 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 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.