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Medivance, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 321 SOUTH TAYLOR AVENUE, LOUISVILLE, CO, 80027
Website: crbard.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)526-4455
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3003329224
DUNS Number: 027183008

Catalogue (57)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Arctic Sun® Temperature Management System, Cleaning Solution	73905	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Calibration Test Unit	74100L	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, RS232 Cord	76200	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, ArcticGel™ Pads	31700	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Temperature Simulator	77700	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System Assy, Cable, Temp Out, Phono Plug GE	73555	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Temperature Out Cable Philips	73556	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, ArcticGel™ Pads	31801	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, ArcticGel™ Pads	31802	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, ArcticGel™ Pads	31707	FDA UDI	Class II	Active
Arctic Sun® 5000	50000000	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Shunt Line	70904	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Transmission Interface Module	76100	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Temperature Cable Bard	73503	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Upgrade (v 2.0.1)	76500	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Transmission Interface Module Kit	76000	FDA UDI	Class II	Active
Arctic Sun Stat	60000000	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Calibration Test Unit	74100	FDA UDI	Class II	Active
Arctic Sun® 5000	50000000L	FDA UDI	Class II	Active
Arctic Sun Stat Temperature Management System	72800	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Power Cord	73300	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Temperature Out Cable Rusch	73554	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Fluid Delivery Lines	73407	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Bracket Assembly	76300	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Service Kit Model 5000	77100	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, ArcticGel™ Pads	31702	FDA UDI	Class II	Active
Arctic Sun Stat	60000000L	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Patient Temperature Simulator	74800	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, ArcticGel™ Pads	31709	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Temperature Cable Philips	73506	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Temp Out Cable, Simms/Lemo Connector	73552	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Drain Bag	70905	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Fluid Delivery Lines	73408	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Strap Kit, Fluid Delivery Line	73490	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, ArcticGel™ Pads	31705	FDA UDI	Class II	Active
Arctic Sun® 5000	50000000E	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Fluid Delivery Lines	73407L	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Temperature Cable Phono	73505	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Temperature Cable Nellcor	73502	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Drain Tube	71900	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, ArcticGel™ Pads	31703	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Temperature Cable Rusch	73504	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Fill Tube	71800	FDA UDI	Class II	Active
Arctic Sun® Temperature Management System, Temp Out Cable, Bard/Lemo Connector	73553	FDA UDI	Class II	Active
Arctic Sun® 5000 Control Panel Screen Protector	75300	FDA UDI	Class II	Active
Arctic Sun Stat Temperature Management System	K243942	FDA 510(k)	Class II	Active
Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad	K142702	FDA 510(k)	Class II	Active
Medivance Nasogastric Tube Temperature Sensor	K110956	FDA 510(k)	Class II	Active
Arctic Sun Temperature Management System	K161602	FDA 510(k)	Class II	Active
Arctic Sun Temperature Management System (Model 5000)	K251974	FDA 510(k)	Class II	Active

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jun 27, 2024	Z-2457-2024	—	open, classified	If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air flow by an obstruction or dirty filter, then system may not alert, and alarm absence may lead to hypothermia or hyperthermia, so a software update will be released to correct issue.
Feb 16, 2024	Z-1381-2024	—	open, classified	Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system.
Jan 5, 2005	Z-0436-05	—	terminated	Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.