THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC

Address:401 MILLCREEK RD.,MARIETTA,OH,45750,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

Accessory, Assisted Reproduction (MQG) (8) Refrigerator, Freezer, Blood Storage (KSE) (2)

Premarket Exempt

No Yes

Clear

Thermo Scientific ™ - 00815773020878 Catalog Number : TDEC06386LV

Device Description : TDEC06386LV; Chest ULT 3cu ft. , 230V, 50Hz

Device Class : 2

Duns Number: 791530061

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Thermo Scientific ™ - 00815773020885 Catalog Number : TDEC39686LA

Device Description : TDEC39686LA; Chest ULT 20 cu. ft., 115V, 60Hz

Device Class : 2

Duns Number: 791530061

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Thermo Scientific Forma - 10815773020004 Catalog Number : 310

Device Description : Direct Heat CO2 Incubator

Device Class : 2

Duns Number: 791530061

Premarket Exempt : No

Product Code : MQG

Prescription Use : Yes

Device Count : 1

Thermo Scientific Forma - 10815773020011 Catalog Number : 311

Device Description : Direct Heat CO2 Incubator

Device Class : 2

Duns Number: 791530061

Premarket Exempt : No

Product Code : MQG

Prescription Use : Yes

Device Count : 1

Thermo Scientific Forma - 10815773020028 Catalog Number : 320

Device Description : Direct Heat CO2 Incubator

Device Class : 2

Duns Number: 791530061

Premarket Exempt : No

Product Code : MQG

Prescription Use : Yes

Device Count : 1

Thermo Scientific Forma - 10815773020035 Catalog Number : 321

Device Description : Direct Heat CO2 Incubator

Device Class : 2

Duns Number: 791530061

Premarket Exempt : No

Product Code : MQG

Prescription Use : Yes

Device Count : 1

Thermo Scientific Forma - 10815773020042 Catalog Number : 350

Device Description : Direct Heat CO2 Incubator

Device Class : 2

Duns Number: 791530061

Premarket Exempt : No

Product Code : MQG

Prescription Use : Yes

Device Count : 1

Thermo Scientific Forma - 10815773020059 Catalog Number : 351

Device Description : Direct Heat CO2 Incubator

Device Class : 2

Duns Number: 791530061

Premarket Exempt : No

Product Code : MQG

Prescription Use : Yes

Device Count : 1

Thermo Scientific Forma - 10815773020066 Catalog Number : 360

Device Description : Direct Heat CO2 Incubator

Device Class : 2

Duns Number: 791530061

Premarket Exempt : No

Product Code : MQG

Prescription Use : Yes

Device Count : 1

Thermo Scientific Forma - 10815773020073 Catalog Number : 361

Device Description : Direct Heat CO2 Incubator

Device Class : 2

Duns Number: 791530061

Premarket Exempt : No

Product Code : MQG

Prescription Use : Yes

Device Count : 1

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