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

EC1350BL - 00851962007428 Catalog Number :

Device Description : 13.5 cu ft zone heating combination warmer

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

ivNext - 00851962007435 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

P-2150 - 00851962007442 Catalog Number :

Device Description : 13.5 cu ft zone heating combination warmer

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

GET1350BL - 00851962007459 Catalog Number :

Device Description : 13.5 cu ft zone heating combination warmer

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

EC400L - 00851962007473 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

EC550BL - 00851962007497 Catalog Number :

Device Description : 30" width single cavity zone heating blanket and fluid warmer

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

P-2420 - 00851962007503 Catalog Number :

Device Description : 30" width single cavity zone heating blanket and fluid warmer, 18" depth

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

GET550BL - 00851962007527 Catalog Number :

Device Description : 30" width single cavity zone heating blanket and fluid warmer

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

P-2430 - 00851962007534 Catalog Number :

Device Description : 30" width single cavity zone heating blanket and fluid warmer, 24" depth

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

MEDIVNOW - 00851962007572 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

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