BELMONT INSTRUMENT CORPORATION

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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) (7) Pump, Infusion (FRN) (3) Warmer, Thermal, Infusion Fluid (LGZ) (3)

Premarket Exempt

No Yes

Clear

CureWrap™ - 07290107580649 Catalog Number : 500-T3525

Device Description : Accessory for the CritiCool system. A body wrap connected to the CritiCool.

Device Class :

Duns Number: 078330362

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

CureWrap™ - 07290107580656 Catalog Number : 500-T3531

Device Description : Accessory for the CritiCool system. A body wrap connected to the CritiCool.

Device Class :

Duns Number: 078330362

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

CureWrap™ - 07290107580663 Catalog Number : 500-T3536

Device Description : Accessory for the CritiCool system. A body wrap connected to the CritiCool.

Device Class :

Duns Number: 078330362

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

CureWrap™ - 07290107580670 Catalog Number : 500-T3541

Device Description : Accessory for the CritiCool system. A body wrap connected to the CritiCool.

Device Class :

Duns Number: 078330362

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

CureWrap™ - 07290107580687 Catalog Number : 500-T3548

Device Description : Accessory for the CritiCool system. A body wrap connected to the CritiCool.

Device Class :

Duns Number: 078330362

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Allon 2001 - 07290107581103 Catalog Number : 200-00263

Device Description : Thermoregulation System

Device Class : 2

Duns Number: 078330362

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

CritiCool - 07290107581110 Catalog Number : 200-00236

Device Description : Thermoregulation System

Device Class : 2

Duns Number: 078330362

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

3.0 Liter Reservoir - 10896128002005 Catalog Number :

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : FRN, LGZ

Prescription Use : Yes

Device Count : 1

ENGLISH, RAPID INFUSER, 120 V, 750 ML/MIN - 10896128002012 Catalog Number :

Device Description : FLUID WARMER, 120 V SYSTEM BOXED

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : FRN, LGZ

Prescription Use : Yes

Device Count : 1

3-Spike Disposable Set - 10896128002029 Catalog Number :

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : FRN, LGZ

Prescription Use : Yes

Device Count : 1

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