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, Blood, Non-Electromagnetic Radiation (BSB) (9) Pump, Infusion (FRN) (1) Warmer, Thermal, Infusion Fluid (LGZ) (1)

Premarket Exempt

No Yes

Clear

Australian, Rapid Infuser, 230 V, 1000ml/min - 00896128002619 Catalog Number :

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : FRN, LGZ

Prescription Use : Yes

Device Count : 1

buddy, 120V SYSTEM - 00896128002640 Catalog Number :

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

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : BSB

Prescription Use : Yes

Device Count : 1

buddy,230V SYSTEM - 00896128002657 Catalog Number :

Device Description : buddy, 230V SYSTEM, FRENCH STANDARD EUROPEAN CORD

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : BSB

Prescription Use : Yes

Device Count : 1

buddy,230V SYSTEM - 00896128002664 Catalog Number :

Device Description : buddy, 230V SYSTEM, GERMAN STANDARD EUROPEAN CORD

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : BSB

Prescription Use : Yes

Device Count : 1

buddy,230V SYSTEM - 00896128002671 Catalog Number :

Device Description : buddy, 230V SYSTEM, ENGLISH, ISRAEL CORD

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : BSB

Prescription Use : Yes

Device Count : 1

buddy,230V SYSTEM - 00896128002688 Catalog Number :

Device Description : buddy, 230V SYSTEM, ITALIAN, STANDARD EUROPEAN CORD

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : BSB

Prescription Use : Yes

Device Count : 1

buddy,230V SYSTEM - 00896128002695 Catalog Number :

Device Description : buddy, 230V SYSTEM, DUTCH, STANDARD EUROPEAN CORD

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : BSB

Prescription Use : Yes

Device Count : 1

buddy,230V SYSTEM - 00896128002701 Catalog Number :

Device Description : buddy, 230V SYSTEM, ENGLISH, UK CORD

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : BSB

Prescription Use : Yes

Device Count : 1

buddy,230V SYSTEM - 00896128002718 Catalog Number :

Device Description : buddy, 230V SYSTEM,GERMAN, SWITZERLAND CORD

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : BSB

Prescription Use : Yes

Device Count : 1

buddy,230V SYSTEM - 00896128002725 Catalog Number :

Device Description : buddy, 230V SYSTEM,FRENCH, SWITZERLAND CORD

Device Class : 2

Duns Number: 078330362

Premarket Exempt : No

Product Code : BSB

Prescription Use : Yes

Device Count : 1

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