VITA HEAT MEDICAL

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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

Patient Warming Mattress - 00851446007005 Catalog Number :

Device Description : The Model 4003 Patient Warming Mattress is an electrical patient warming mattres The Model 4003 Patient Warming Mattress is an electrical patient warming mattress that is connected to a Model 2002 Controller and is powered by Model 100026-PA AC Power Adapter or Model 100026 Battery. The Patient Warming Mattress provides warmth for a patient.

Device Class : 2

Duns Number: 021249224

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Controller - 00851446007012 Catalog Number :

Device Description : The Model 2002 Controller regulates the temperature of and the power to the Mode The Model 2002 Controller regulates the temperature of and the power to the Model 4003 Patient Warming Mattress. It is powered by Model 100026-PA AC Power Adapter or Model 100026 Battery. The Controller monitors current, zone power, the temperature sensors, and detects faults in the mattress or system.

Device Class : 2

Duns Number: 021249224

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Battery - 00851446007036 Catalog Number :

Device Description : The Model 100026 Battery provides power to the Model 2002 Controller. The Batte The Model 100026 Battery provides power to the Model 2002 Controller. The Battery is charged by the 3001-C Battery Charger.

Device Class : 2

Duns Number: 021249224

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Battery Charger - 00851446007043 Catalog Number :

Device Description : The Model 3001-C Battery Charger provides charging power to a Model 100026 Batteries.

Device Class : 2

Duns Number: 021249224

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

AC Power Adapter - 00851446007067 Catalog Number :

Device Description : The Model 100026-PA AC Power Adapter Provides power to the Model 2002 Controller.

Device Class : 2

Duns Number: 021249224

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Battery Power Subassembly - 00851446007081 Catalog Number :

Device Description : The Model 300126 Battery Power Subassembly is Model 3001-C Battery Charger and Q The Model 300126 Battery Power Subassembly is Model 3001-C Battery Charger and QTY 2 Model 100026 Batteries as a subassembly, but is packaged separately from a system configuration.

Device Class : 2

Duns Number: 021249224

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

AC Power Adapter Subassembly Kit - 00851446007098 Catalog Number :

Device Description : The Model 100026-PA-SA AC Power Adapter Subassembly is a Model 100026-PA AC Powe The Model 100026-PA-SA AC Power Adapter Subassembly is a Model 100026-PA AC Power Adapter as a subassembly. This includes Model 100026-PA, but is packaged seperately from a system configuration.

Device Class : 2

Duns Number: 021249224

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

VitaHEAT UB3 Patient Warming System - Battery Power - 00851446007104 Catalog Number :

Device Description : The Model 7003-A, VitaHEAT UB3 Patient Warming System - Battery Power includes a The Model 7003-A, VitaHEAT UB3 Patient Warming System - Battery Power includes a Model 4003 Patient Warming Mattress, a Model 2002 Controller, QTY 2 Model 100026 Batteries, and a Model 3001-C Battery Charger.

Device Class : 2

Duns Number: 021249224

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

VitaHEAT UB3 Patient Warming System - AC Power - 00851446007128 Catalog Number :

Device Description : The Model 7003-B, VitaHEAT UB3 Patient Warming System - AC Power includes Model The Model 7003-B, VitaHEAT UB3 Patient Warming System - AC Power includes Model 4003 Patient Warming Mattress, Model 2002 Controller, and Model 100026-PA AC Power Adapter.

Device Class : 2

Duns Number: 021249224

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

VitaHEAT UB3 Patient Warming System- Battery and AC Power - 00851446007142 Catalog Number :

Device Description : The Model 7003-C, VitaHEAT UB3 Patient Warming System- Battery and AC Power incl The Model 7003-C, VitaHEAT UB3 Patient Warming System- Battery and AC Power includes Model 4003 Patient Warming Mattress, Model 2002 Controller, AC Power Adapter, QTY 2 Model 100026 Batteries, and Model 3001-C Battery Charger.

Device Class : 2

Duns Number: 021249224

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

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