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® 5000 Control Panel Screen Protector - 00801741080470 Catalog Number : 75300

Device Description : Arctic Sun® 5000 Control Panel Screen Protector

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® Temperature Management System, Service Kit Model 5000 - 00801741080487 Catalog Number : 77100

Device Description : Arctic Sun® Temperature Management System, Service Kit Model 5000

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® Temperature Management System, Temperature Simulator - 00801741080531 Catalog Number : 77700

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

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® Temperature Management System, Fluid Delivery Lines - 00801741080548 Catalog Number : 73407L

Device Description : Arctic Sun® Temperature Management System, Fluid Delivery Lines

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® 5000 - 00801741127755 Catalog Number : 50000000E

Device Description : Arctic Sun® 5000

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® Temperature Management System, Transmission Interface Module Kit - 00801741127762 Catalog Number : 76000

Device Description : Arctic Sun® Temperature Management System, Transmission Interface Module Kit

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® Temperature Management System, Transmission Interface Module - 00801741127779 Catalog Number : 76100

Device Description : Arctic Sun® Temperature Management System, Transmission Interface Module

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® Temperature Management System, RS232 Cord - 00801741127786 Catalog Number : 76200

Device Description : Arctic Sun® Temperature Management System, RS232 Cord

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® Temperature Management System, Bracket Assembly - 00801741127793 Catalog Number : 76300

Device Description : Arctic Sun® Temperature Management System, Bracket Assembly

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® Temperature Management System, Upgrade (v 2.0.1) - 00801741127809 Catalog Number : 76500

Device Description : Arctic Sun® Temperature Management System, Upgrade (v 2.0.1)

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

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