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

Warmer, Thermal, Infusion Fluid (LGZ) (7) Pump, Infusion (FRN) (4) Warmer, Blood, Non-Electromagnetic Radiation (BSB) (3)

Premarket Exempt

No Yes

Clear

Hyperthermia Pump Y-Set Pt Line Kit, w/ (2) 4.4L Reservoir - 00896128002480 Catalog Number :

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : LGZ

Prescription Use : Yes

Device Count : 1

BUDDY LITE - 00896128002497 Catalog Number :

Device Description : ASSY, BUDDY LITE BATTERY HOUSING AND HEATER UNIT

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : BSB

Prescription Use : Yes

Device Count : 1

buddy, Power Module - 00896128002503 Catalog Number :

Device Description : Assy, buddy, Power Module 120V, Unit

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : BSB

Prescription Use : Yes

Device Count : 1

buddy, 120V SYSTEM - 00896128002510 Catalog Number :

Device Description : buddy, 120V SYSTEM, ENGLISH US CORD

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : BSB

Prescription Use : Yes

Device Count : 1

Belmont 3.0 Liter Disposable Set x 4 - 00896128002534 Catalog Number :

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : LGZ, FRN

Prescription Use : Yes

Device Count : 1

Chinese, Rapid Infuser, 230 V, 750ml/min - 00896128002558 Catalog Number :

Device Description : Fluid Warmer, 230V UNIT, 750ml/min

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : LGZ, FRN

Prescription Use : Yes

Device Count : 1

Chinese, Rapid Infuser, 230 V, 1000ml/min - 00896128002565 Catalog Number :

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : LGZ, FRN

Prescription Use : Yes

Device Count : 1

Hyperthermia Pump Procedure Pack - 00896128002572 Catalog Number :

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : LGZ

Prescription Use : Yes

Device Count : 1

Hyperthermia Pump Procedure Kit - 00896128002589 Catalog Number :

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : LGZ

Prescription Use : Yes

Device Count : 1

Australian, Rapid Infuser, 230 V, 750ml/min - 00896128002602 Catalog Number :

Device Description : Fluid Warmer, 230V UNIT, 750ml/min

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : LGZ, FRN

Prescription Use : Yes

Device Count : 1

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