Nasal Endotracheal Tube Holder Kit
The Nasal Endotracheal Tube Holder Kit is a convenience kit that contains components used to secure a nasally placed endotracheal tube, maintaining airway access during anesthesia or mechanical ventilation. Classified as FDA Class 1 under regulation 21 CFR 868.5770 within the Anesthesiology medical specialty, it is subject only to general controls and falls under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance, exempting it from 510(k) requirements. The product code is OGI. It is not designated as an implant or life-sustaining device.
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Basic Information
- Product Code
- OGI
- Device Class
- FDA class 1
- Regulation Number
- 868.5770
- 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 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.