Home GUDID 07290012127953 Acc. Kit for Adult with Interface Cables Only for Disposable Sensors
Primary DI 07290012127953
Brand Acc. Kit for Adult with Interface Cables Only for Disposable Sensors
Company BELMONT INSTRUMENT CORPORATION
Model 200-00310
Catalog number 200-00310
Device description Accessory kit for the thermoregulation System
Published 2016-09-26
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07290012127953 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07290012127953 07290012127953 7290012127953
GMDN Terms# Term, Definition table Term Definition Circulating-fluid whole-body heating/cooling system control unit A mains electricity (AC-powered) device intended to be used as part of a circulating-fluid whole-body heating/cooling system to control/regulate the temperature and flow of fluid through a connected patient-applied pad (not included), for heating and alternatively cooling a patient’s whole-body (i.e., elevate or lower core body temperature). The device includes a heater and refrigeration unit, a pump, and typically a water reservoir; it may also be intended for patient temperature monitoring and typically includes alarms for cases of water temperatures beyond pre-set limits. It is intended to be used by a healthcare professional in a clinical setting (e.g., to achieve normothermia).
Regulatory Flags# DUNS number 078330362 Device count 1 Premarket exempt true Kit true Serial number true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 17290012127332 CureWrap™ Pediatric, 79-91cm (8 pack) 500-03531 500-03531 2016-09-24 07290012127175 CureWrap™ Adult Over 135 cm 500-03500 500-03500 2016-09-24 07290012127182 CureWrap™ Infant, 2.5-4Kg 500-03518 500-03518 2016-09-24 07290012127199 CureWrap™ Infant, 4-7Kg (single) 500-03521 500-03521 2016-09-24 07290012127328 CureWrap™ Infant, 7-11Kg, (single) 500-03525 500-03525 2016-09-24 07290012127342 CureWrap™ Pediatric 91-104cm, (single) 500-03536 500-03536 2016-09-24 07290012127380 CureWrap™ Pediatric 122–135cm (single) 500-03548 500-03548 2016-09-24 07290107580625 CureWrap™ Infant (single) 500-T3518 2016-09-24 07290012127205 ThermoWrap™ Universal 79–91cm (single) 500-03131 500-03131 2016-09-24 07290012127212 ThermoWrap™ Universal, 91–104cm (single) 500-03136 500-03136 2016-09-24 07290012127229 ThermoWrap™ Universal, 104–122cm (single) 500-03141 500-03141 2016-09-24 07290012127236 ThermoWrap™ Pediatric, 122–135cm, (single) 500-03148 500-03148 2016-09-24 07290012127243 ThermoWrap™ Universal 135-152cm, (single) 500-03153 500-03153 2016-09-24 07290012127250 ThermoWrap™ Universal 152-168cm (single) 500-03160 500-03160 2016-09-24 07290012127267 ThermoWrap™ Universal, Adults, 168-180cm, (single) 500-03166 500-03166 2016-09-24 07290012127274 ThermoWrap™ Cardiac 165-172cm, (single) 500-03363 500-03363 2016-09-24 07290012127281 ThermoWrap™ Infant, 2.5–4.0Kg,(single) 500-03118 500-03118 2016-09-24 07290012127298 ThermoWrap™ Infant, 4.0–7.0Kg, (single) 500-03121 500-03121 2016-09-24 07290012127304 ThermoWrap™ Infant, 7.0–11Kg, (single) 500-03125 500-03125 2016-09-24 07290012127373 CureWrap™ Pediatric 104–122cm (single) 500-03541 500-03541 2016-09-24
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