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

English, Rapid Infuser, 230 V, 750ml/min - 10896128002036 Catalog Number :

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : LGZ, FRN

Prescription Use : Yes

Device Count : 1

Dual Patient Line - 10896128002050 Catalog Number :

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : LGZ, FRN

Prescription Use : Yes

Device Count : 1

Patient Line Extension - 10896128002067 Catalog Number :

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : FRN, LGZ

Prescription Use : Yes

Device Count : 1

Fluid Replacement Supply - 10896128002081 Catalog Number :

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : FRN, LGZ

Prescription Use : Yes

Device Count : 1

BUDDY DISPOSABLE SET - 10896128002098 Catalog Number :

Device Description : BUDDY DISPOSABLE SET, 24 SETS PER BOX

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : BSB

Prescription Use : Yes

Device Count : 1

buddy, Power Module, 230V - 10896128002104 Catalog Number :

Device Description : buddy, Power Module 230V

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : BSB

Prescription Use : Yes

Device Count : 1

BUDDY, HEATER - 10896128002111 Catalog Number :

Device Description : BUDDY HEATER UNIT

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : BSB

Prescription Use : Yes

Device Count : 1

English, Hyperthermia Pump, 230V - 10896128002135 Catalog Number :

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : LGZ

Prescription Use : Yes

Device Count : 1

Hyperthermia Pump Y-Set Pt Line - 10896128002265 Catalog Number :

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : LGZ

Prescription Use : Yes

Device Count : 1

Hyperthermia Pump Cannula Connector - 10896128002289 Catalog Number :

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : LGZ

Prescription Use : Yes

Device Count : 1

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