HYPOTHERMIA DEVICES, INC.

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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

Pack, Hot Or Cold, Water Circulating (ILO) (7)

Premarket Exempt

Yes

Clear

Kelvi - 00850001185004 Catalog Number :

Device Description : Kelvi Pro Console

Device Class : 2

Duns Number: 079330735

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Kelvi - 00850001185011 Catalog Number :

Device Description : Kelvi Pro Umbilical

Device Class : 2

Duns Number: 079330735

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Kelvi - 00850001185028 Catalog Number :

Device Description : Kelvi Shoulder Pro Smart Wrap

Device Class : 2

Duns Number: 079330735

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Kelvi - 00850001185035 Catalog Number :

Device Description : Kelvi Back Pro Smart Wrap

Device Class : 2

Duns Number: 079330735

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Kelvi - 00850001185042 Catalog Number :

Device Description : Kelvi Knee Pro Smart Wrap

Device Class : 2

Duns Number: 079330735

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Kelvi - 00850001185059 Catalog Number :

Device Description : Kelvi Ankle Pro Smart Wrap

Device Class : 2

Duns Number: 079330735

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Kelvi - 00850001185073 Catalog Number :

Device Description : Kelvi Hand Station

Device Class : 2

Duns Number: 079330735

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

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