FDA.reportPublic FDA data

ThermoWrap™ Infant, 2.5–4.0Kg,(single)

Primary DI
07290012127281
Brand
ThermoWrap™ Infant, 2.5–4.0Kg,(single)
Company
BELMONT INSTRUMENT CORPORATION
Model
500-03118
Catalog number
500-03118
Device description
Accessory for the Allon systems. A body wrap connected to the thermoregulation system.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWJSystem, Thermal Regulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWJSystem, Thermal RegulatingCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K024128000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024128000ALLON 2001 VERSION 5Mtre Advanced Technology , Ltd.2003-02-10DWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37290012127282PackageGS124In Commercial Distribution
07290012127281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3729001212728237290012127282
07290012127281072900121272817290012127281

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid whole-body heating/cooling system control unitA 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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+2152591020info@mmi.co.il

Regulatory Flags#

DUNS number
078330362
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
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
07290107580199CureWrap™ Pediatric 91-104cm (single)500-03536PED-L10012016-09-24

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