FDA.reportPublic FDA data

MEDIVANCE, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
17250563003329224MEDIVANCE, INC.1N2026-01-01321 SOUTH TAYLOR AVENUE SUITE 200 LOUISVILLE CO US 80027
30039820033003982003MEDIVANCE INSTRUMENTS LTD.1N2026-01-01BARRETTS GREEN ROAD HARLESDEN, LONDON London, City of GB NW10 7AP

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00801741080005Arctic Sun® Temperature Management System, ArcticGel™ Pads - 31700+1(800)526-4455medical.services@crbard.com
00801741080029Arctic Sun® Temperature Management System, ArcticGel™ Pads - 31702+1(800)526-4455medical.services@crbard.com
00801741080043Arctic Sun® Temperature Management System, ArcticGel™ Pads - 31703+1(800)526-4455medical.services@crbard.com
00801741080067Arctic Sun® Temperature Management System, ArcticGel™ Pads - 31705+1(800)526-4455medical.services@crbard.com
00801741080081Arctic Sun® Temperature Management System, ArcticGel™ Pads - 31707+1(800)526-4455medical.services@crbard.com
00801741080104Arctic Sun® Temperature Management System, ArcticGel™ Pads - 31709+1(800)526-4455medical.services@crbard.com
00801741080128Arctic Sun® Temperature Management System, ArcticGel™ Pads - 31801+1(800)526-4455medical.services@crbard.com
00801741184314Arctic Sun Stat Temperature Management System - Arctic Sun Stat Temperature Management System Fill Tube+1(844)823-5483lou.customerservice@bd.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1463881996148034K251974Arctic Sun Temperature Management System (Model 5000)DWJ2025-10-24
1463881244616393K243942Arctic Sun Stat Temperature Management SystemDWJ2025-04-30
1463881414219778K200225Arctic Sun Stat Temperature Management SystemDWJ2020-02-28
1463881010397142K161602Arctic Sun Temperature Management SystemDWJ2016-09-02
1463881159824533K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel PadDWJ2014-12-18
606601782355732K111167XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINTIXW2011-08-18
606601367195175K093503INTRAX FILM PROCESSORIXW2010-01-06
606601800200906K024105VELOPEX AQUACUT FLUID ABRASION UNITKOJ2003-10-09
1463881625836894
606601994496140

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DWJ52025-10-24
IXW42011-08-18
KOJ22003-10-09

PMN#

GUDID#

56 records. Showing 1-40. Next