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) (9) Pump, Infusion (FRN) (7) Warmer, Blood, Non-Electromagnetic Radiation (BSB) (1)

Premarket Exempt

No Yes

Clear

Swedish, Rapid Infuser, 230 V, 750ml/min - 00896128002350 Catalog Number :

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

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : FRN, LGZ

Prescription Use : Yes

Device Count : 1

UK, Rapid Infuser, 230 V, 750ml/min - 00896128002367 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

Spanish, Rapid Infuser, 230 V, 1000ml/min - 00896128002381 Catalog Number :

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : FRN, LGZ

Prescription Use : Yes

Device Count : 1

Swedish, Rapid Infuser, 230 V, 1000ml/min - 00896128002398 Catalog Number :

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : LGZ, FRN

Prescription Use : Yes

Device Count : 1

Turkish, Rapid Infuser, 230 V, 1000ml/min - 00896128002404 Catalog Number :

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : LGZ, FRN

Prescription Use : Yes

Device Count : 1

UK, Rapid Infuser, 230 V, 1000ml/min - 00896128002411 Catalog Number :

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : FRN, LGZ

Prescription Use : Yes

Device Count : 1

British Military, Rapid Infuser, 230 V, 750ml/min - 00896128002428 Catalog Number :

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

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : FRN, LGZ

Prescription Use : Yes

Device Count : 1

BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT - 00896128002442 Catalog Number :

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

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : BSB

Prescription Use : Yes

Device Count : 1

Turkish, Hyperthermia Pump, 230V - 00896128002466 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, 4.4L Reservoir - 00896128002473 Catalog Number :

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : LGZ

Prescription Use : Yes

Device Count : 1

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