MEDIVANCE, INC.

FDA Device Registration & Listing · LOUISVILLE, CO, US · Registration 1725056

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1725056
FEI Number
3003329224
Entity Name
MEDIVANCE, INC.
City/State/Country
LOUISVILLE, CO, US
Establishment Address
321 SOUTH TAYLOR AVENUE, SUITE 200, LOUISVILLE, CO 80027, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
C. R. Bard, Inc. (Owner Number: 2212754)
Owner / Operator Contact Address
1 Becton Drive, Franklin Lakes, NJ 07417, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K251974
PMA Number
N/A

All Registered Proprietary Names

ArcticGel Pads Arctic Sun Temperature Management System Arctic Sun Stat Temperature Management System Arctic Sun Stat Temperature Management System Arctic Sun Temperature Management System (Model 5000)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2015-01-08
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2016-09-07
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2025-08-01
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2020-06-17
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2025-12-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

C. R. Bard, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3006513822 Lutonix, Inc. Tempe, AZ, US
1223089 DAVOL INC. WOBURN, MA, US
3002504068 Bard European Distribution Center NV Olen Antwerpen, BE
1213643 DAVOL INC., SUB. C.R. BARD, INC. Warwick, RI, US
1424526 BARD BRACHYTHERAPY, INC CAROL STREAM, IL, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K171373 3M Company 3M Bair Hugger Model 675 Total Temperature Management System 2017-10-10
K083336 Smiths Medical Asd, Inc. LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL 2009-06-03

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0035-2010 Cincinnati Sub-Zero Products Inc 2
WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1725056. Last updated year: 2026. Please use registration number 1725056 when referencing this establishment in official correspondence.
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