Tracheostomy Cleaning Tray
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
1 recall events for this product code
Registered firms
17 firms currently registered for this product code
Medline Soluciones Medicas
Nuevo Laredo Tamaulipas, MX
Isomedix Operations Inc
EL PASO, TX, US
Medline Industries, Lp - Laredo
LAREDO, TX, US
Cardinal Health 200, Llc
El Paso, TX, US
Sterigenics Us Llc
Grand Prairie, TX, US
Sterigenics U.s., Llc
Charlotte, NC, US
Cardinal Health 200, Llc
Waukegan, IL, US
Midwest Sterilization Corp.
JACKSON, MO, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Medline Industries, Lp - Northfield
Northfield, IL, US
Allmed Industrial Limited
Shenzhen City Guangdong, CN
Midwest Sterilization Corp.
LAREDO, TX, US
Allmed Medical Products Co., Ltd.
ZHIJIANG CITY Hubei, CN
Isomedix Operations Inc
El Paso, TX, US
Allmed Medical Products Co., Ltd.
Zhijiang City Hubei, CN
Nuevo Laredo Directo Al Cliente
Nuevo Laredo Tamaulipas, MX
Amsino Medical (shanghai) Co., Ltd.
SHANGHAI, CN
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.