HELMER, INC.

Address:14400 Bergen Blvd,NOBLESVILLE,IN,46060,US

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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

Refrigerator, Freezer, Blood Storage (KSE) (10)

Premarket Exempt

No Yes

Clear

Horizon Series™ - 00816394021541 Catalog Number :

Device Description : -30°C Laboratory Freezer, 25 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

i.Series® - 00816394021558 Catalog Number :

Device Description : -30°C Blood Bank Freezer - Undercounter, 5 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Horizon Series™ - 00816394021565 Catalog Number :

Device Description : -30°C Blood Bank Freezer - Undercounter, 5 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

i.Series® - 00816394021572 Catalog Number :

Device Description : -30°C Blood Bank Freezer, 20 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Horizon Series™ - 00816394021589 Catalog Number :

Device Description : -30°C Blood Bank Freezer, 20 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

i.Series® - 00816394021596 Catalog Number :

Device Description : -30°C Blood Bank Freezer, 25 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Horizon Series™ - 00816394021602 Catalog Number :

Device Description : -30°C Blood Bank Freezer, 25 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

i.Series® - 00816394021619 Catalog Number :

Device Description : Ultra-Low Freezer, 16 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

i.Series® - 00816394021626 Catalog Number :

Device Description : Ultra-Low Freezer, 18 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

i.Series® - 00816394021633 Catalog Number :

Device Description : Ultra-Low Freezer, 24 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

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