Oxygen Administration Kit
Anesthesiology · 21 CFR 868.5655
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
13 adverse event reports on file
- INFANT HEATED WIRE CIRCUITAug 8, 2018MalfunctionVyaire Medical8030673-2018-00010
- AIRLIFE¿ INFANT HEATED WIRE CIRCUITAug 8, 2018InjuryVyaire Medical8030673-2018-00009
- INFANT HEATED WIRE CIRCUITAug 8, 2018InjuryVyaire Medical8030673-2018-00008
- AIRLIFE¿ INFANT HEATED WIRE CIRCUITAug 7, 2018MalfunctionVyaire Medical8030673-2018-00006
- AIRLIFE¿ INFANT HEATED WIRE CIRCUITAug 7, 2018MalfunctionVyaire Medical8030673-2018-00007
- INFANT HEATED WIRE CIRCUITAug 3, 2018InjuryVyaire Medical8030673-2018-00004
- AIRLIFEFeb 6, 2018MalfunctionCarefusion7244792
- CIRCUIT, ADULT DUAL-LIMB, DUAL-HEATJan 3, 2018InjuryVyaire Medical, Inc8030673-2018-00400
- CIRCUIT, ADULT SINGLE-LIMB, HEATEDDec 12, 2017InjuryVyaire Medical, Inc8030673-2017-00393
- CIRCUIT, ADULT DUAL-LIMB, DUAL-HEATNov 27, 2017InjuryVyaire Medical, Inc8030673-2017-00385
Event type breakdown
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
16 firms currently registered for this product code
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
Sterigenics Us Llc
Grand Prairie, TX, US
Sterigenics U.s., Llc
Charlotte, NC, US
Westmed, Inc.
TUCSON, AZ, US
Cardinal Health 200, Llc
El Paso, TX, US
Bound Tree Medical, Llc
Grand Prairie, TX, US
Isomedix Operations Inc
EL PASO, TX, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Sunset Healthcare Solutions Central Warehouse
Elgin, IL, US
Tri-tech Forensics, Inc.
Leland, NC, US
Cardinal Health 200, Llc
Waukegan, IL, US
Productos Urologos De Mexico S.a. De C.v.
MEXICALI Baja California, MX
Marken Healthtech Limited
NASHIK Maharashtra, IN
Isomedix Operations Inc
El Paso, TX, US
Aero-med Llc
East Hartford, CT, US
Westmed Javid De Mexico, S.a. De C.v.
NOGALES Sonora, MX
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.