Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1219702

FEI Number

1219702

Entity Name

BELMONT MEDICAL TECHNOLOGIES

City/State/Country

BILLERICA, MA, US

Establishment Address

780 Boston Rd, BILLERICA, MA 01821, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BELMONT INSTRUMENT LLC. (Owner Number: 1219702)

Owner / Operator Contact Address

780 BOSTON RD., --, Billerica, MA 01821, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K090508

PMA Number

N/A

All Registered Proprietary Names

The Belmont® Rapid Infuser FMS2000 3 Liter Reservoir (6 Count) 3 Liter Disposable Set 3 Liter Reservoir (1 Piece) Dual Patient Line (1 Piece) Dual Patient Line Patient Line Extension (1 Piece) Rapid Infuser RI-2, 120V, 1000ml/min Patient Line Extension 3-Spike Disposable Set Rapid Infuser RI-2, 120V, 750ml/min 3-Spike Disposable Set (1 Piece) CritiCool® CureWrap TM Pediatric 104-122cm (single) CureWrap Infant, 4-7Kg (single) CureWrap TM Adult Over 135 cm CureWrap Pediatric 91- 104cm, (single) CureWrap Infant, 2.5-4Kg CureWrap Infant, 7-11Kg, (single) CureWrap Pediatric, 79- 91cm (8 pack) CureWrap TM Pediatric 122- 135cm (single) Allon 2001 ® ThermoWrap TM Universal 152- 168cm (single) ThermoWrap TM Universal, 104-122cm (single) ThermoWrap TM Universal, Adults, 168-180cm, (single) ThermoWrap TM Universal, 91- 104cm (single) ThermoWrap TM Infant, 7-11Kg, (Single) ThermoWrap TM Infant, 2.5- 4Kg,(single) ThermoWrap TM Universal 135- 152cm, (single) ThermoWrap TM Pediatric, 122- 135cm, (single) ThermoWrap TM Universal 79- 91cm (single) ThermoWrap TM Cardiac 165- 172cm, (single) ThermoWrap TM Infant, 4- 7Kg, (single) Rapid Infuser Accessory Kit Buddy Lite Blood/Fluid Warmer Buddy Disposable Set, 6 X Box 24=144 Buddy Disposable Set, 24 sets per box Buddy Disposable Set, One piece

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2020-10-15
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2014-02-28
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2025-01-02
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2025-01-02
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2018-08-24
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2018-08-24
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2014-02-28
BSB	Warmer, Blood, Non-Electromagnetic Radiation	Hematology	Class 2	864.9205	2009-05-22

Official Correspondent

Lida Reed

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BELMONT INSTRUMENT LLC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K090508	Belmont Instrument Corp.	THE BELMONT BUDDY LITE FLUID WARMER	2009-03-26
K171373	3M Company	3M Bair Hugger Model 675 Total Temperature Management System	2017-10-10
K083336	Smiths Medical Asd, Inc.	LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL	2009-06-03
K913718	Abbott Laboratories	PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED	1991-10-30
K840616	Advanced Bio Systems, Inc.	MINI-PUMP U-100	1984-03-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2010	Cincinnati Sub-Zero Products Inc	2	WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.
Z-0001-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
Z-0002-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163.
Z-0005-2025	Zyno Medical LLC	2	Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Z-0006-2011	CareFusion Corporation	2	CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems.

Similar Registrations

Registration Number	Establishment Name	Location
9617604	ICU Medical Healthcare Manufacturing S.A. de C.V.	Tijuana, B.C. C.P. Baja California, MX
2432320	NOVAMED-USA	Elmsford, NY, US
3012315097	CARE ESSENTIALS INTERNATIONAL PVT LTD.	Ahmedabad Gujarat, IN
9680284	3M EDUMEX, S.A DE C.V	CD. JUAREZ Chihuahua, MX
3012307300	ICU Medical, Inc.	Minneapolis, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1219702. Last updated year: 2026. Please use registration number 1219702 when referencing this establishment in official correspondence.