ENTHERMICS, INC.

ENTHERMICS, 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

Warmer, Thermal, Infusion Fluid (LGZ) (10)

Premarket Exempt

No Yes

Clear

ivNow - 00851962007008 Catalog Number :

Device Description : modular fluid warmer

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

EC230L - 00851962007015 Catalog Number :

Device Description : 2.3 cu ft halo heat fluid warmer

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

EC340L - 00851962007022 Catalog Number :

Device Description : 3.4 cu ft halo heat fluid warmer

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

EC390L - 00851962007039 Catalog Number :

Device Description : 3.9 cu ft halo heat fluid warmer

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

EC770L - 00851962007046 Catalog Number :

Device Description : 7.7 cu ft halo heat fluid warmer

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

EC1540BL - 00851962007053 Catalog Number :

Device Description : 15.4 cu ft halo heat combination warmer

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

EC1260BL - 00851962007060 Catalog Number :

Device Description : 12.6 cu ft halo heat combination warmer

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

EC1730BL - 00851962007077 Catalog Number :

Device Description : 17.3 cu ft halo heat combination warmer

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

DC250L - 00851962007084 Catalog Number :

Device Description : 2.5 cu ft zone heating fluid warmer

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

DC400L - 00851962007091 Catalog Number :

Device Description : 4.0 cu ft zone heating fluid warmer

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

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