THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC

Address:275 Aiken Rd,ASHEVILLE,NC,28804,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

Thermo Scientific ™ CryoMed™ - 00815773020472 Catalog Number : TSCM48CA

Device Description : TSCM48CA; CRF CTS MD 48L w/o print 120V

Device Class : 2

Duns Number: 791530061

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Thermo Scientific ™ CryoMed™ - 00815773020489 Catalog Number : TSCM17TA

Device Description : TSCM17TA; CRF CTS MD 17L w/print 120V

Device Class : 2

Duns Number: 791530061

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Thermo Scientific ™ CryoMed™ - 00815773020496 Catalog Number : TSCM34TA

Device Description : TSCM34TA; CRF CTS MD 34L w/print 120V

Device Class : 2

Duns Number: 791530061

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Thermo Scientific ™ CryoMed™ - 00815773020502 Catalog Number : TSCM48TA

Device Description : TSCM48TA; CRF CTS MD 48L w/print 120V

Device Class : 2

Duns Number: 791530061

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Thermo Scientific ™ - 00815773020519 Catalog Number : TDEC39686LD

Device Description : TDEC39686LD, Chest ULT 20 cu. ft., 208-230V, 60Hz

Device Class : 2

Duns Number: 791530061

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Thermo Scientific ™ - 00815773020526 Catalog Number : TDEC39686LV

Device Description : TDEC39686LV, Chest ULT 20 cu. ft., 230V, 50Hz

Device Class : 2

Duns Number: 791530061

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Thermo Scientific ™ - 00815773020830 Catalog Number : TDEC25286LA

Device Description : TDEC25286LA, Chest ULT 12.7 cu ft., 115V, 60Hz

Device Class : 2

Duns Number: 791530061

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Thermo Scientific ™ - 00815773020847 Catalog Number : TDEC25286LD

Device Description : TDEC25286LD; Chest ULT 12.7 cu.ft. , 208-230V, 60Hz

Device Class : 2

Duns Number: 791530061

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Thermo Scientific ™ - 00815773020854 Catalog Number : TDEC25286LV

Device Description : TDEC25286LV; Chest ULT 12.7 cu.ft. , 230V, 50Hz

Device Class : 2

Duns Number: 791530061

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Thermo Scientific ™ - 00815773020861 Catalog Number : TDEC06386LA

Device Description : TDEC06386LA; Chest ULT 3cu ft. , 115V, 60Hz

Device Class : 2

Duns Number: 791530061

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

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