FDA.reportPublic FDA data

CritiCool Pro

Primary DI
07290107580526
Brand
CritiCool Pro
Company
M.T.R.E. ADVANCED TECHNOLOGIES LTD.
Model
VL4000N 115VAC
Catalog number
100-00013
Device description
Thermoregulation System combined with a patient monitor.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWJSystem, Thermal Regulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWJSystem, Thermal RegulatingCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290107580526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290107580526072901075805267290107580526

GMDN Terms#

Term, Definition table
TermDefinition
Single-patient intensive/general healthcare physiologic monitoring systemAn assembly of electrically-powered devices designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically includes a central station monitor that receives, consolidates, and displays the information, and/or a bedside patient monitor; it often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
532022530
Device count
1
Premarket exempt
true
Combination product
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290107580540CritiCool Pro VL4000M 115VAC100-001132016-09-24
07290107580564CritiCool Pro VL4500N 115VAC100-002132016-09-24
07290107580588CritiCool Pro VL4500M 115VAC100-003132016-09-26
07290102932313CritiCool ProVitaLogik4000 3/5Lead,NI Nellcor Blue681-0R0-0132016-09-24
07290102932337CritiCool ProVitaLogik4000 3/5Lead,NI Masimo Blue681-0R0-0232016-09-24
07290102932344CritiCool ProVitaLogik4500 3/5Lead Nellcor Blue681-0R0-1132016-09-24
07290012127335CureWrap™Pediatric, 79-91cm (single)500-035312016-09-24
07290102932351CritiCool ProVitaLogik4500 3/5Lead Masimo Blue681-0R0-1232016-09-24
07290102932368CerebralogikModule CC Set Color681-138-0002016-09-24
07290102932375Cerebralogik Module VL Set Color681-138-0102016-09-24
07290102932382Cerebralogik aEEG VL4X00_Kit 681-OPT-1382016-09-24
07290102932399Cerebralogik aEEG VL6X00_Kit781OPT1382016-09-24
77290107580242CureWrap™X-Large Pediatric 122-135 cm (single)PED-X10012016-09-24
77290107580266CureWrap™X-Large Pediatric over 135cm (single)PED-X20012016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08719867002646Mistral-Air®The Surgical Company International B.V.DWJ2024-07-08
08719867002660Mistral-Air®The Surgical Company International B.V.DWJ2024-07-08
10193489134773MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
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10197344012794MedlineMEDLINE INDUSTRIES, INC.DWJ2024-04-30
09332017002885CocoonCARE ESSENTIALS PTY LTDDWJ2023-01-20
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