FDA.reportPublic FDA data

Chinese, Rapid Infuser, 230 V, 1000ml/min

Primary DI
00896128002565
Brand
Chinese, Rapid Infuser, 230 V, 1000ml/min
Company
BELMONT INSTRUMENT CORPORATION
Model
903-00024-C
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FRNPump, Infusion
LGZWarmer, Thermal, Infusion Fluid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2
LGZWarmer, Thermal, Infusion FluidGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091855000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091855000THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000Belmont Instrument Corp.2009-07-01FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00896128002565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896128002565008961280025658961280025650896128002565

GMDN Terms#

Term, Definition table
TermDefinition
Warming/high-flow infusion pumpA mains electricity (AC-powered) device designed to warm and rapidly infuse blood and other solutions (e.g., crystalloid and colloid) into a patient during high-blood-loss surgical procedures; it is also used for burn and trauma cases. Maximum flow rates may exceed 1 L/min.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078330362
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290012127332CureWrap™ Pediatric, 79-91cm (8 pack)500-03531500-035312016-09-24
07290012127175CureWrap™ Adult Over 135 cm500-03500500-035002016-09-24
07290012127182CureWrap™ Infant, 2.5-4Kg500-03518500-035182016-09-24
07290012127199CureWrap™ Infant, 4-7Kg (single)500-03521500-035212016-09-24
07290012127328CureWrap™ Infant, 7-11Kg, (single)500-03525500-035252016-09-24
07290012127342CureWrap™ Pediatric 91-104cm, (single) 500-03536500-035362016-09-24
07290012127380 CureWrap™ Pediatric 122–135cm (single)500-03548500-035482016-09-24
07290107580625CureWrap™Infant (single)500-T35182016-09-24
07290012127205ThermoWrap™ Universal 79–91cm (single)500-03131500-031312016-09-24
07290012127212ThermoWrap™ Universal, 91–104cm (single)500-03136500-031362016-09-24
07290012127229ThermoWrap™ Universal, 104–122cm (single)500-03141500-031412016-09-24
07290012127236ThermoWrap™ Pediatric, 122–135cm, (single)500-03148500-031482016-09-24
07290012127243ThermoWrap™ Universal 135-152cm, (single)500-03153500-031532016-09-24
07290012127250ThermoWrap™ Universal 152-168cm (single) 500-03160500-031602016-09-24
07290012127267ThermoWrap™ Universal, Adults, 168-180cm, (single)500-03166500-031662016-09-24
07290012127274ThermoWrap™ Cardiac 165-172cm, (single)500-03363500-033632016-09-24
07290012127281ThermoWrap™ Infant, 2.5–4.0Kg,(single)500-03118500-031182016-09-24
07290012127298ThermoWrap™ Infant, 4.0–7.0Kg, (single)500-03121500-031212016-09-24
07290012127304ThermoWrap™ Infant, 7.0–11Kg, (single)500-03125500-031252016-09-24
07290012127373 CureWrap™ Pediatric 104–122cm (single) 500-03541500-035412016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCFRN2026-02-24
08719867002752Fluido® AirGuard SystemThe Surgical Company International B.V.LGZ2025-09-12
07613327626391ThermaClearSTRYKER CORPORATIONLGZ2025-04-04
17290016740209QINFLOW AC STATION INTRO SET EXTREMEQUALITY IN FLOW LTDLGZ2025-02-18
17290109155309Sapphire M.T. Pump Kit CEITAN MEDICAL LTDFRN2024-09-04
09008247000235Extension SetBiegler GmbHLGZ2024-06-04
09008247000242Extension SetBiegler GmbHLGZ2024-06-04
18719867001561Fluido® CompactThe Surgical Company International B.V.LGZ2024-02-09
18719867001776Fluido® CompactThe Surgical Company International B.V.LGZ2024-02-09
18719867001806Fluido® CompactThe Surgical Company International B.V.LGZ2024-02-09
10815112021396CardioGen-82 Infusion System Model 1700Bracco Diagnostics Inc.FRN2023-12-01
10815112021358CardioGen Patient Administration SetBracco Diagnostics Inc.FRN2023-10-16
17290109155149Sapphire Epidural Infusion Kit - US EITAN MEDICAL LTDFRN2023-09-05
17290016740162QinFlow Warrior Lite set with 1 Lite Extra Power BatteryQUALITY IN FLOW LTDLGZ2023-01-05
17290016740049QINFLOW WARRIOR HYBRID INTRO SET QUALITY IN FLOW LTDLGZ2023-01-04
17290109154272Sapphire Epidural Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-15
17290109154289Sapphire M.T Infusion Pump Kit- US - S kit EITAN MEDICAL LTDFRN2022-05-15
17290109154265Sapphire M.T Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-11
107073877927223M™ Ranger™3M COMPANYLGZ2021-06-21
10814844000365Curlin IV Pump SystemZEVEX INTERNATIONAL, INC.FRN2021-04-29
10190752147102enFlow™AIRLIFELGZ2021-03-29
10190752178281enFlow™AIRLIFELGZ2021-03-29
09008247000259Extension SetBiegler GmbHLGZ2020-06-19
15019517177367PharmGuardICU MEDICAL, INC.FRN2020-03-20
15019517177374PharmGuardICU MEDICAL, INC.FRN2020-03-20
10884521064843KangarooCardinal Health, Inc.FRN2019-12-30
15019517155143MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517155150MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517155167MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517178067MedfusionICU MEDICAL, INC.FRN2019-09-18