Orotracheal Intubation Guide Kit
Anesthesiology · 21 CFR 868.1400
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.
Recent MDR events
3 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- superDimension, IncTerminatedJul 12, 2012
superDimension Systems AAS00016-xx with Software Version 4.0-4.9.
superDimension, Inc., is conducting a recall of certain superDimension Systems operating Software Version 4.0 - 4.9. The affected systems are sold under the product code AAS00016-xx. The products being recalled have been found to malfunction when connected to the superDimension Locatable Guide (LG). Specifically, the Systems using Software Version 4.0-4.9 will not recognize the Locatable Guide
Z-2001-2012 · View FDA record ↗ - Smiths Medical ASD Inc.TerminatedUnknown
smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
The incorrect device is contained in the package.
Z-2401-2021 · View FDA record ↗
Registered firms
14 firms currently registered for this product code
Isomedix Operations Inc
EL PASO, TX, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Bryan Medical Inc.
Cincinnati, OH, US
Sterigenics U.s., Llc
Charlotte, NC, US
Bound Tree Medical, Llc
Grand Prairie, TX, US
Lsl Healthcare
Niles, IL, US
Nar Medical Depot, Llc
Greer, SC, US
Isomedix Operations Inc
El Paso, TX, US
Cardinal Health 200, Llc
Waukegan, IL, US
Deroyal Industries, Inc.
POWELL, TN, US
Quadrant Technologies, Llc
Grayslake, IL, US
Sterigenics Us Llc
Grand Prairie, TX, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Cardinal Health 200, Llc
El Paso, TX, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.