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, Drain Bag - 00801741080180 Catalog Number : 70905

Device Description : Arctic Sun® Temperature Management System, Drain Bag

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® Temperature Management System, Fill Tube - 00801741080197 Catalog Number : 71800

Device Description : Arctic Sun® Temperature Management System, Fill Tube

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® Temperature Management System, Drain Tube - 00801741080203 Catalog Number : 71900

Device Description : Arctic Sun® Temperature Management System, Drain Tube

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® Temperature Management System, Power Cord - 00801741080258 Catalog Number : 73300

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

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 - 00801741080265 Catalog Number : 73407

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® Temperature Management System, Fluid Delivery Lines - 00801741080272 Catalog Number : 73408

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® Temperature Management System, Strap Kit, Fluid Delivery Line - 00801741080289 Catalog Number : 73490

Device Description : Arctic Sun® Temperature Management System, Strap Kit, Fluid Delivery Line

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 Nellcor - 00801741080296 Catalog Number : 73502

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

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 Bard - 00801741080302 Catalog Number : 73503

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

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 Rusch - 00801741080319 Catalog Number : 73504

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

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

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