Catheterization lab set

WHO list of priority medical devices
Cardiovascular diseases and diabetes (2021)
Service type
Curative
Life course
All ages
Sex
All
Service delivery platforms
6. Second-level and third-level hospital services and specialized outpatient services
Healthcare unit
Medical imaging
Specialized treatment
Type of medical device
Surgical instruments, trays and bowls
EMDN related* code(s)
V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER
https://webgate.ec.europa.eu/dyna2/emdn
* The codes shown in this section were observed and retrieved from public databases and complemented with the input of Nomenclature Agencies. More information
Capital
No
Reusable
Yes
Requirements
air conditioning / temperature control
electricity (mains)
emergency power supply
HIS/LMIS/RIS/PACS
lighting
radiation protection
waste disposal
Consumables
Labels, sheet of 22, waterproof 1; Marker, skin, dual tip 1;
Level of technical knowledge
General clinical
Regulatory classification (EU)
Class IIa
Directive 93/42/EEC
Regulation (EU) 2017/745
Regulatory classification (FDA)
Class II
PMD books
WHO resources
Kit or set
Set: Catheter Set:(filter, needle with luer, case and cap); Bandbag, 36 x 40 in., with tape 1; Bowl, guidewire, 2500cc 1; Bowl, sponge,16oz., 500cc 1; Bowl, sponge, 32oz., 1000cc 1; Clamps, towel, 41/2 in., plastic, blue, curved 4; Cover, setup, 54 x 90 in. 1; Domebag, 26 in. deep, latex-free 1; Drape, femoral angiography, 80 x 160 in. 1; Forceps, halstead mosquito, 5 in., straight 1; Forceps, halstead mosquito, 5 in., curved 1; Gowns, Astound®, X-Large 2; Introducer, guidewire, 18G x 7cm 1; Medicine cups, 2 oz., 60 cc, graduated 2; Needle holder, nest, foam block 1; Needle holder, webster, 5 in., large rings 1; Needle, 18G x 11/2 in. 1; Needle, 25G x 11/2 in. 1; Scalpel handel with blades, reusable/ single-use; Scissors, 51/2 in., straight, sharp/blunt 1; Sponges, 4 x 4 in., 4-ply 40; Syringes, various sizes; Table cover, 50 x 90 in. 1; Towels; Tray, organizer; PVP scrub or ChloraPrep® skin prep 2; Pressure transducer Kit1; Access sheath(s); Guidewire, .035 J-tipped, 180/300cm lengths; Catheters, diagnotic, Femoral/radial Catheter Set:(Interventional): Catheters, interventional, Femoral/radial; .014 Workhorse guidewire(s) 183/300 length; .014 Specialty guidewire (s); Angioplasty balloons; Cutting balloon(s); Drug-eluting stent(s); Bare-metal stent(s); Covered Stent(s); Balloon deflator
Decommissioning
Other non-WHO resources