M.T.R.E. ADVANCED TECHNOLOGIES LTD.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Thermal Regulating (DWJ) (4)

Premarket Exempt

Yes

Clear

CritiCool Pro - 07290107580526 Catalog Number : 100-00013

Device Description : Thermoregulation System combined with a patient monitor.

Device Class : 2

Duns Number: 532022530

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

CritiCool Pro - 07290107580540 Catalog Number : 100-00113

Device Description : Thermoregulation System combined with patient monitor

Device Class : 2

Duns Number: 532022530

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

CritiCool Pro - 07290107580564 Catalog Number : 100-00213

Device Description : Thermoregulation System combined with patient monitor

Device Class : 2

Duns Number: 532022530

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

CritiCool Pro - 07290107580588 Catalog Number : 100-00313

Device Description : Thermoregulation System combined with patient monitor

Device Class : 2

Duns Number: 532022530

Premarket Exempt : Yes

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

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