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® - 00816394021244 Catalog Number :

Device Description : Laboratory Refrigerator, 25 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Horizon Series™ - 00816394021251 Catalog Number :

Device Description : Laboratory Refrigerator, 25 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

i.Series® - 00816394021268 Catalog Number :

Device Description : Pharmacy Refrigerator, 25 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Horizon Series™ - 00816394021275 Catalog Number :

Device Description : Pharmacy Refrigerator, 25 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

i.Series® - 00816394021282 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

Horizon Series™ - 00816394021299 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® - 00816394021305 Catalog Number :

Device Description : Laboratory Refrigerator, 45 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Horizon Series™ - 00816394021312 Catalog Number :

Device Description : Laboratory Refrigerator, 45 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

i.Series® - 00816394021329 Catalog Number :

Device Description : Pharmacy Refrigerator, 45 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Horizon Series™ - 00816394021336 Catalog Number :

Device Description : Pharmacy Refrigerator, 45 cu ft

Device Class : 2

Duns Number: 086685682

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

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