Airway Suction Kit
Anesthesiology · 21 CFR 868.6810
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
9 adverse event reports on file
- AIRLIFEDec 16, 2025InjuryAirlife8030647-2025-00140
- AIRLIFE, TRI-FLO SUCTION CATH-N-GLOVE KITFeb 6, 2025MalfunctionVyarrie Medical8030673-2025-00008
- CATHETER SUCT 2GLOVE W/BASIN 10FR 100/CSAug 4, 2021Injury8030673-2021-00184
- CATHETER SUCT DRY RIGID 08FR KITMay 6, 2021Malfunction8030673-2021-00167
- CATHETER SUCT 2GLOVE W/BASIN 10FR 100/CSMar 15, 2021MalfunctionVyaire Medical8030673-2021-00154
- CATHETER SUCT DRY RIGID 08FR KIT 100/CSJan 6, 2021MalfunctionVyaire Medical Inc.8030673-2020-00144
- AIRLIFE TRI-FLO SUNCTION CATH-N-GLOVE KITOct 4, 2019MalfunctionVyaire Medical, Inc.9156034
- CATH-N-GLOVE SET 2-GLOVE 5/6FRMay 30, 2019MalfunctionVyaire Medical8030673-2019-00043
- AIRLIFE TRI-FLOMar 6, 2014MalfunctionMedical Components, Inc.3697209
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
17 firms currently registered for this product code
Isomedix Operations Inc
El Paso, TX, US
Hilbro (pvt) Ltd.
SIALKOT Punjab, PK
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
Sterigenics U.s., Llc
Ontario, CA, US
Cardinal Health 200, Llc
El Paso, TX, US
Bound Tree Medical, Llc
Grand Prairie, TX, US
Sterigenics U.s., Llc
Charlotte, NC, US
Invidia Medical Gmbh U Co Kg
Emmingen-Liptingen Baden-Wurttemberg, DE
Isomedix Operations Inc
EL PASO, TX, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Bls Systems, Ltd.
OAKVILLE Ontario, CA
Smd Manufacturing Llc
Salt Lake City, UT, US
North American Rescue, Llc.
Greer, SC, US
Sterigenics Us Llc
Grand Prairie, TX, US
Cardinal Health 200, Llc
Waukegan, IL, US
Productos Urologos De Mexico S.a. De C.v.
MEXICALI Baja California, MX
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.