Custom Anesthesia Tray
The Custom Anesthesia Tray is a convenience kit that packages a customized selection of anesthesia-related components tailored to specific procedural or institutional needs. Classified as FDA Class 2 under regulation 21 CFR 868.5120 within the Anesthesiology medical specialty, it falls under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance and does not require a 510(k) submission when all applicable criteria are met. The product code is OGD. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OGD
- Device Class
- FDA class 2
- Regulation Number
- 868.5120
- 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 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.