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Belmont Instrument Corp.

Last updated May 23, 2026

Information

Country: US
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Catalogue (219)

Page 1 of 5

Device	Model / Reference	Registries	Class	Status
English, Hyperthermia Pump, 230V	902-00001A	FDA UDI	Class II	Unknown
Norwegian, Rapid Infuser, 230 V, 1000ml/min	903-00024-N	FDA UDI	Class II	Unknown
UK, Rapid Infuser, 230 V, 1000ml/min	903-00024-UK	FDA UDI	Class II	Unknown
UK, Rapid Infuser, 230 V, 750ml/min	903-00001A-UK	FDA UDI	Class II	Unknown
Acc. Kit for Infant with Reusable Temperature Sensor	200-00420	FDA UDI	N/A	Active
Buddy Lite With Ac, Battery Housing And Heater Unit, Uk	905-00024	FDA UDI	Class II	Unknown
Straight Inflow/Bifurcated Outflow Pt Line Kit	902-00038	FDA UDI	Class II	Active
Patient Line Extension	903-00022	FDA UDI	Class II	Active
Hyperthermia Pump St In/Out Pt Line	902-00010P	FDA UDI	Class II	Unknown
Buddy Lite, Battery Housing And Heater Unit, Uk	905-00018	FDA UDI	Class II	Unknown
buddy, 230V SYSTEM	905-00001A-E-UK	FDA UDI	Class II	Unknown
Cerebralogik aEEG	Kit (CC PRO)	FDA UDI	Class II	Unknown
British Military, Rapid Infuser RI-2, 230V, 750 ml/min	903-00039A-BM	FDA UDI	Class II	Unknown
Acc. Kit for Adult with Reusable Temperature Sensor	200-00400	FDA UDI	N/A	Active
German, Hyperthermia Pump, 230V	902-00001A-G	FDA UDI	Class II	Unknown
buddy, 230V SYSTEM	905-00001A-D-SE	FDA UDI	Class II	Unknown
ThermoWrap™ Infant, 2.5–4.0Kg, (single)	500-03118	FDA UDI	Class II	Active
Acc. Kit for Adult with Interface Cables Only for Disposable Sensors	200-00410	FDA UDI	N/A	Active
Buddy Lite With Ac, Battery Housing And Heater Unit, Switzerland	905-00025	FDA UDI	Class II	Unknown
Spanish, Rapid Infuser RI-2, 230V, 750 ml/min	903-00039A-S	FDA UDI	Class II	Unknown
ThermoWrap™ Universal, 104–122cm (single)	500-03141	FDA UDI	Class II	Active
Hyperthermia Pump Y-Set Pt Line	902-00004	FDA UDI	Class II	Unknown
Patient Line Extension (1 Piece)	903-00022P	FDA UDI	Class II	Active
ThermoWrap™ Cardiac 165-172cm, (single)	500-03363	FDA UDI	Class II	Active
French, Rapid Infuser, 230 V, 1000ml/min	903-00024-F	FDA UDI	Class II	Unknown
English, Rapid Infuser RI-2, 230V, 1000 ml/min	903-00037A	FDA UDI	Class II	Unknown
UK, Rapid Infuser RI-2, 230V, 1000 ml/min	903-00037A-UK	FDA UDI	Class II	Unknown
Rapid Infuser RI-2, 120V, 1000ml/min	903-00037	FDA UDI	Class II	Active
CureWrap™	Adult (single)	FDA UDI	Class II	Unknown
Turkish, Hyperthermia Pump, 230V	902-00001A-T	FDA UDI	Class II	Unknown
Hyperthermia Pump Thoracic Catheter	902-00043	FDA UDI	Class II	Unknown
Hyperthermia Pump St In/Out Pt Line Kit w/ 3L Reservoir	902-00007	FDA UDI	Class II	Unknown
Buddy Lite, Battery Housing And Heater Unit, Netherlands	905-00029	FDA UDI	Class II	Unknown
ThermoWrap™ Universal 79–91cm (single)	500-03131	FDA UDI	Class II	Active
buddy, 230V SYSTEM	905-00001A-I-SW	FDA UDI	Class II	Unknown
Australian, Rapid Infuser, 230 V, 750ml/min	903-00001A-AUS	FDA UDI	Class II	Unknown
CureWrap™ Medium2 Pediatric 79-91 cm (single)	500-03531	FDA UDI	Class II	Unknown
Buddy Liter With Ac, Battery Housing And Heater Unit, North American	905-00035	FDA UDI	Class II	Unknown
buddy 2 SYSTEM	905-00037-D	FDA UDI	Class II	Unknown
Turkish, Rapid Infuser, 230 V, 1000ml/min	903-00024-T	FDA UDI	Class II	Unknown
Hyperthermia Pump Accessory	902-00011	FDA UDI	Class II	Unknown
British Military, Rapid Infuser RI-2, 230V, 1000 ml/min	903-00037A-BM	FDA UDI	Class II	Unknown
CureWrap™ Pediatric 104-122cm (single)	500-03541	FDA UDI	Class II	Unknown
Turkish, Rapid Infuser, 230 V, 750ml/min	903-00001A-T	FDA UDI	Class II	Unknown
Portuguese, Rapid Infuser RI-2, 230V, 750 ml/min	903-00039A-P	FDA UDI	Class II	Unknown
buddy lite® Blood/Fluid Warmer	905-00017	FDA UDI	Class II	Active
buddy™ Disposable Set (1 Piece)	905-00010P	FDA UDI	Class II	Active
Rapid Infuser RI-2, 120V, 750 ml/min	903-00039	FDA UDI	Class II	Active
CritiCool	200-00236	FDA UDI	Class II	Active
Acc. Kit for Infant with Interface Cables Only for Disposable Sensors	200-00330	FDA UDI	N/A	Active

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FDA Recalls (8)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 13, 2025	Z-1966-2025	—	open, classified	An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The Human Sensor Board is disconnected from the Controller Board in the Allon device AND the temperature alarms are disabled, or 2. The Water In and Water Out and Thermostat sensors are disconnected from the Human Sensor Board AND the temperature alarms are disabled, the device will proceed to heat the water above the hardware fault limit without notifying the user of the faulty condition.
Mar 31, 2025	Z-1674-2025	—	open, classified	Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
Mar 31, 2025	Z-1675-2025	—	open, classified	Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
Mar 31, 2025	Z-1676-2025	—	open, classified	Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
Mar 31, 2025	Z-1678-2025	—	open, classified	Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.
Jan 2, 2025	Z-1099-2025	—	open, classified	Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set
Jul 20, 2021	Z-0153-2023	—	open, classified	Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failure to deliver the prescribed thermoregulation therapy. To date, the firm has received one report of death potentially related to this issue.
Sep 25, 2012	Z-0058-2013	—	terminated	Leak from a saline bag caused saline to drip along the back of the Rapid infuser close to the Power Entry Module causing an electrical flash at the power entry area.