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

EC2120BL - 00851962007107 Catalog Number :

Device Description : 21.2 cu ft zone heating combination warmer

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

EC250L - 00851962007237 Catalog Number :

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

EC350L - 00851962007305 Catalog Number :

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

EC1850BL - 00851962007312 Catalog Number :

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

GET250L - 00851962007329 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-2112 - 00851962007336 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

GET350L - 00851962007343 Catalog Number :

Device Description : 3.5 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-2122 - 00851962007350 Catalog Number :

Device Description : 3.5 cu ft zone heating fluid warmer

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

GET1850BL - 00851962007367 Catalog Number :

Device Description : 18.5 cu ft zone heating combination warmer

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

P-2147 - 00851962007374 Catalog Number :

Device Description : 18.5 cu ft zone heating combination warmer

Device Class : 2

Duns Number: 139782767

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

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