BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT,AUSTRALIA

Primary DI
60896128002444
Brand
BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT,AUSTRALIA
Company
BELMONT INSTRUMENT CORPORATION
Model
905-00040
Device description
ASSY, BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT, AUSTRALIA CHARGER
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
BSBWarmer, Blood, Non-Electromagnetic Radiation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSBWarmer, Blood, Non-Electromagnetic RadiationHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112639000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112639000THE BELMONT BUDDY LITE FLUID WARMERBelmont Instrument Corp.2011-11-16BSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60896128002444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6089612800244460896128002444

GMDN Terms#

Term, Definition table
TermDefinition
Conduction blood/fluid warmerA mains electricity (AC-powered) device, which may include rechargeable batteries, designed for in-line heating of banked blood, blood products, intravenous (IV) solutions, and irrigation fluids, typically from about 4ºC to near body temperature (i.e., 35 to 37ºC) before infusion, through the conduction of heat. The device usually includes a surface heat exchanger (e.g., heated dry plate) for the conduction of heat to the infusion blood/fluid via a disposable set (e.g., tubing or pouch); it also includes temperature controls and/or alarms. It is typically mounted on an IV pole under the infusion bag; it does not infuse blood/fluid.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
507073878034023M™ Ranger™3M COMPANYBSB2026-04-26
07290016740202Warrior AC StationQUALITY IN FLOW LTDBSB2025-02-18
17290016740209QINFLOW AC STATION INTRO SET EXTREMEQUALITY IN FLOW LTDBSB2025-02-18
37290016740166QINFLOW WARRIOR LITE SET WITH LITE BATTERYQUALITY IN FLOW LTDBSB2025-02-18
37290016740203QINFLOW AC STATION INTRO SET WARRIORQUALITY IN FLOW LTDBSB2025-02-18
47290016740163QINFLOW WARRIOR LITE SET WITH 2 LITE BATTERYQUALITY IN FLOW LTDBSB2025-02-18
47290016740200QINFLOW AC STATION EXTENDED SET WARRIORQUALITY IN FLOW LTDBSB2025-02-18
05745000140015°M Warmer System - Starter KitMequ A/SBSB2024-10-30
05745000140022°M Warmer System - Starter Kit+Mequ A/SBSB2024-10-30
05700002076816°M Warmer System - °M WarmerMequ A/SBSB2024-10-09
05700002076823°M Warmer System - °M WarmerMequ A/SBSB2024-10-09
05700002076847°M Warmer System - ChargerMequ A/SBSB2024-10-09
05745000140039°M Warmer System - Power PackMequ A/SBSB2024-10-09
05745000140046°M Warmer System - Power Pack+Mequ A/SBSB2024-10-09
04260114141433ASTOTUBE®Stihler Electronic GmbHBSB2024-08-16
04260114141440ASTOTUBE®Stihler Electronic GmbHBSB2024-08-16
04260114141389ASTOTUBE®Stihler Electronic GmbHBSB2024-08-16
04260114141396ASTOTUBE®Stihler Electronic GmbHBSB2024-08-16
20896128002095buddy™ Disposable SetBELMONT INSTRUMENT CORPORATIONBSB2024-04-15
00861816000345TA-UPC Ultra Power Cable 3'Estill Medical Technologies, Inc.BSB2024-03-28
00861816000390TA-UPC Ultra Power Cable 3'Estill Medical Technologies, Inc.BSB2024-03-28
00861816000307Thermal Angel Estill Medical Technologies, Inc.BSB2023-12-31
00861816000314Thermal Angel Estill Medical Technologies, Inc.BSB2023-12-31
00861816000338Thermal Angel Ultra Battery 1Estill Medical Technologies, Inc.BSB2023-12-31
17290016740162QinFlow Warrior Lite set with 1 Lite Extra Power BatteryQUALITY IN FLOW LTDBSB2023-01-05
27290016740169QinFlow Warrior Lite set with 2 Lite Extra Power BatteryQUALITY IN FLOW LTDBSB2023-01-05
07290016740042AC Power supply ModuleQUALITY IN FLOW LTDBSB2023-01-04
07290016740097QIF-01-12 extended kit QUALITY IN FLOW LTDBSB2023-01-04
07290016740103Warrior Lite Blood and Fluid Warmer Base UnitQUALITY IN FLOW LTDBSB2023-01-04
07290016740110Rechargeable Lite BatteryQUALITY IN FLOW LTDBSB2023-01-04