HELMER, INC.

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

i.Series® - 00816394020001 Catalog Number :

Device Description : Blood Bank Refrigerator - Undercounter, 4 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

i.Series® - 00816394020018 Catalog Number :

Device Description : Blood Bank Refrigerator - Undercounter, 5 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

i.Series® - 00816394020025 Catalog Number :

Device Description : Blood Bank Refrigerator, 11 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

i.Series® - 00816394020032 Catalog Number :

Device Description : Blood Bank Refrigerator, 20 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

i.Series® - 00816394020049 Catalog Number :

Device Description : Blood Bank Refrigerator, 25 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

i.Series® - 00816394020056 Catalog Number :

Device Description : Blood Bank Refrigerator - Pass-Thru, 26.5 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

i.Series® - 00816394020063 Catalog Number :

Device Description : Blood Bank Refrigerator, 45 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

i.Series® - 00816394020070 Catalog Number :

Device Description : Blood Bank Refrigerator, 56 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

i.Series® - 00816394020087 Catalog Number :

Device Description : Blood Bank Refrigerator - Pass-Thru, 58 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Horizon Series™ - 00816394020094 Catalog Number :

Device Description : Blood Bank Refrigerator - Undercounter, 4 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

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