Product code OGI

Device name

Nasal Endotracheal Tube Holder Kit

Medical specialty

Anesthesiology

Device class

1

Regulation number

868.5770

Review panel

AN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset