Tracheostomy Kit
Anesthesiology · 21 CFR 868.5800
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 type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
Recent MDR events
3 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
13 firms currently registered for this product code
Isomedix Operations Inc
EL PASO, TX, US
Sterigenics Us Llc
Grand Prairie, TX, US
Cardinal Health 200, Llc
El Paso, TX, US
Lsl Healthcare
Niles, IL, US
Isomedix Operations Inc
El Paso, TX, US
Chinook Medical Gear, Inc.
Tulsa, OK, US
Medical Action Industries, Inc. 306
ARDEN, NC, US
Atos Medical Ab
HORBY Skane, SE
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Sterigenics U.s., Llc
Charlotte, NC, US
Honduras Kitting, S.a.
Villanueva Cortes, HN
Midwest Sterilization Corp.
JACKSON, MO, US
Cardinal Health 200, Llc
Waukegan, IL, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.