Medivance, Inc.

Address:321 SOUTH TAYLOR AVENUE,LOUISVILLE,CO,80027,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, thermal regulating (DWJ) (10)

Premarket Exempt

Clear

Arctic Sun® Temperature Management System, Temperature Cable Phono - 00801741080326 Catalog Number : 73505

Device Description : Arctic Sun® Temperature Management System, Temperature Cable Phono

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® Temperature Management System, Temperature Cable Philips - 00801741080333 Catalog Number : 73506

Device Description : Arctic Sun® Temperature Management System, Temperature Cable Philips

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® Temperature Management System, Temp Out Cable, Simms/Lemo Connector - 00801741080340 Catalog Number : 73552

Device Description : Arctic Sun® Temperature Management System, Temp Out Cable, Simms/Lemo Connector

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® Temperature Management System, Temp Out Cable, Bard/Lemo Connector - 00801741080357 Catalog Number : 73553

Device Description : Arctic Sun® Temperature Management System, Temp Out Cable, Bard/Lemo Connector

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® Temperature Management System, Temperature Out Cable Rusch - 00801741080364 Catalog Number : 73554

Device Description : Arctic Sun® Temperature Management System, Temperature Out Cable Rusch

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® Temperature Management System Assy, Cable, Temp Out, Phono Plug GE - 00801741080371 Catalog Number : 73555

Device Description : Arctic Sun® Temperature Management System Assy, Cable, Temp Out, Phono Plug GE

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® Temperature Management System, Temperature Out Cable Philips - 00801741080388 Catalog Number : 73556

Device Description : Arctic Sun® Temperature Management System, Temperature Out Cable Philips

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® Temperature Management System, Cleaning Solution - 00801741080401 Catalog Number : 73905

Device Description : Arctic Sun® Temperature Management System, Cleaning Solution

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® Temperature Management System, Calibration Test Unit - 00801741080418 Catalog Number : 74100

Device Description : Arctic Sun® Temperature Management System, Calibration Test Unit

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® Temperature Management System, Patient Temperature Simulator - 00801741080449 Catalog Number : 74800

Device Description : Arctic Sun® Temperature Management System, Patient Temperature Simulator

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

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