Thermo Scientific Freezers TDE30086LA, TDE30086LD, TDE30086LV, TDE40086LA, TDE40086LD, TDE40086LV

Registration Details

Registration Name: THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC
Registration Number: 1523845
FEI Number: 1523845
Status: Active
Expiry Year: 2025
Initial Importer: Yes
Address: 401 MILLCREEK RD.
City: MARIETTA
State: OH
ZIP: 45750
Country: US

Owner / Operator

Firm Name: THERMO FISHER SCIENTIFIC INC.
Operator Number: 2182773
Address: 168 Third Avenue, --
City: Waltham
State: MA
Postal Code: 02451
Country: US

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Refrigerator, Freezer, Blood Storage	KSE	Class 2	Hematology	No	1992-11-04

Proprietary Names

Thermo Scientific Freezers TDE30086LA, TDE30086LD, TDE30086LV, TDE40086LA, TDE40086LD, TDE40086LV Thermo Scientific Forma Blood Bank Refrigerator FRBB5004A, FRBB5004D, FRBB5004V, FRBB5004W Thermo Scientific Freezers TDE50086LA, TDE50086LD, TDE50086LV, TDE60086LA, TDE60086LD, TDE60086LV Thermo Scientific Forma Blood Bank Refrigerator FRBB404A, FRBB404V, FRBB404W Thermo Scientific Revco RDE Series -40 C Ultra-Low Temperature Freezers RDE60040LA, RDE60040LD, RDE60040LV Thermo Scientific CryoMed TSCM34TA (CRF CTS MD 34L w/print 120V) Ultra-Low Temperature Freezer TDEC39686LA Thermo Scientific Blood Bank Refrigerators TSX1204BY, TSX1204BZ Thermo Scientific TDE Series -40 C Ultra-Low Temperature Freezers TDE60040LA, TDE60040LD, TDE60040LV Ultra-Low Temperature Freezer TDEC06386LA Thermo Scientific TSX Series High-Performance Plasma Freezer TSX1230LA, TSX1230LD Thermo Scientific TDE Series -40 C Ultra-Low Temperature Freezers TDE50040LA, TDE50040LD, TDE50040LV Thermo Scientific CryoMed TSCM34EL (CryoMed MD 34L w/ print 100v) Thermo Scientific Jewett Blood Bank Refrigerator BBR55D-1B Thermo Scientific Forma FDE Series -40 C Ultra-Low Temperature Freezers FDE60040LA, FDE60040LD, FDE60040LV Thermo Scientific CryoMed TSCM17ML (CryoMed MD 48L w/o print 100v) Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC25286LA Thermo Scientific Revco Blood Bank Refrigerator REB3004A, REB3004D, REB3004V, REB3004W VWR Series Chest Ultra-Low Temperature Freezer VWRC25286LD Thermo Scientific CryoMed TSCM17EA (CryoMed MD 17L w/ print 120v) Thermo Scientific CryoMed TSCM17MV (CryoMed MD 17L w/o print 230v) Thermo Scientific Forma Blood Bank Refrigerator FRBB2304A, FRBB2304D, FRBB2304V, FRBB2304W Thermo Scientific Revco RDE Series -40 C Ultra-Low Temperature Freezers RDE50040LA, RDE50040LD, RDE50040LV Ultra-Low Temperature Freezer TDEC25286LD Thermo Scientific Revco Blood Bank Refrigerator REB1204D, REB1204V, REB1204W VWR Series Chest Ultra-Low Temperature Freezer VWRC06386LA Thermo Scientific CryoMed TSCM48EV (CryoMed MD 48L w/ print 230v) Ultra-Low Temperature Freezer TDEC39686LV Thermo Scientific Jewett Blood Bank Refrigerator JBB1204A, JBB1204D, JBB1204V, JBB1204W VWR Series Chest Ultra-Low Temperature Freezer VWRC39686LD Thermo Scientific CryoMed TSCM34CA (CRF CTS MD 34L w/o print 120V) Thermo Scientific HERAFreeze Freezers HDE50086LD, HDE50086LV, HDE60086LD, HDE60086LV Thermo Scientific CryoMed TSCM17EV (CryoMed MD 17L w/ print 230v) Thermo Scientific Revco Blood Bank Refrigerator REB2304A, REB2304D, REB2304V, REB2304W Thermo Scientific Jewett Blood Bank Refrigerator BBR25D-2A Thermo Scientific CryoMed TSCM17CA (CRF CTS MD 17L w/o print 120V) Thermo Scientific Revco Freezers RDE30086LA, RDE30086LD, RDE30086LV, RDE40086LA, RDE40086LD, RDE40086LV Thermo Scientific CryoMed TSCM48ML (CryoMed MD 48L w/o print 100v) Thermo Scientific Blood Bank Refrigerators TSX1204BA, TSX1204BD, TSX1204BV Thermo Scientific Jewett Blood Bank Refrigerator JBB3004A, JBB3004D, JBB3004V, JBB3004W VWR Series Chest Ultra-Low Temperature Freezer VWRC25286LA Fisherbrand Isotemp Ultra-Low-Temperature Freezers IUE30086LA, IUE30086LD, IUE30086LV Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC25286LV Thermo Scientific Forma FDE Series -40 C Ultra-Low Temperature Freezers FDE40040LA, FDE40040LD, FDE40040LV Thermo Scientific CryoMed TSCM48EL (CryoMed MD 48L w/ print 100v) Thermo Scientific Forma Blood Bank Refrigerator FRBB1204A, FRBB1204D, FRBB1204V, FRBB1204W HERAfreeze HDE Series -40 C Ultra-Low Temperature Freezers HDE40040LA, HDE40040LD,HDE40040LV Ultra-Low Temperature Freezer TDEC25286LA Thermo Scientific Forma Blood Bank Refrigerator FRBB3004A, FRBB3004D, FRBB3004V, FRBB3004W Fisherbrand Isotemp Ultra-Low-Temperature Freezers IUE60086LA, IUE60086LD, IUE60086LV Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC39686LV Thermo Scientific Forma Freezers FDE30086LA, FDE30086LD, FDE30086LV, FDE40086LA, FDE40086LD, FDE40086LV HERAfreeze HDE Series -40 C Ultra-Low Temperature Freezers HDE60040LA, HDE60040LD,HDE60040LV Thermo Scientific CryoMed TSCM48TA (CRF CTS MD 48L w/print 120V) Ultra-Low Temperature Freezer TDEC06386LV Thermo Scientific TSX Series High-Performance Plasma Freezer TSX3030LA, TSX3030LD Thermo Scientific TSX Universal Series ULT Freezer TSX60086LA Thermo Scientific Revco RDE Series -40 C Ultra-Low Temperature Freezers RDE40040LA, RDE40040LD, RDE40040LV Ultra-Low Temperature Freezer TDEC25286LV Thermo Scientific TSX Series High-Performance Plasma Freezer TSX5030LA, TSX5030LD Thermo Scientific Jewett Blood Bank Refrigerator JBB5004A, JBB5004D, JBB5004V, JBB5004W HERAfreeze HDE Series -40 C Ultra-Low Temperature Freezers HDE50040LA, HDE50040LD,HDE50040LV Thermo Scientific Forma Ultra Low Temperature Freezer FDE60086MA, FDE60086MD, FDE60086MV Thermo Scientific Blood Bank Refrigerators TSX3004BY, TSX3004BZ Thermo Scientific CryoMed TSCM48MV (CryoMed MD 48L w/o print 230v) Thermo Scientific Jewett Blood Bank Refrigerator JBB2304A, JBB2304D, JBB2304V, JBB2304W Thermo Scientific TSX Series High-Performance Blood Bank Refrigerator TSX2304BA, TSX2304BD, TSX2304BV Thermo Scientific TSX Universal Series ULT Freezer TSX70086LA Thermo Scientific TDE Series -40 C Ultra-Low Temperature Freezers TDE40040LA, TDE40040LD, TDE40040LV Thermo Scientific CryoMed TSCM34ML (CryoMed MD 34L w/o print 100v) Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC25286LD Thermo Scientific CryoMed TSCM17EL (CryoMed MD 17L w/ print 100v) Thermo Scientific Jewett Blood Bank Refrigerator BBR55D-2A VWR Series Chest Ultra-Low Temperature Freezer VWRC39686LA Thermo Scientific CryoMed TSCM34MA (CryoMed MD 34L w/o print 120v) Thermo Scientific CryoMed TSCM34EA (CryoMed MD 34L w/ print 120v) Thermo Scientific Plasma Freezer TSX3030LV, TSX3030LY, TSX3030LZ Thermo Scientific HERAFreeze Freezers HDE60086LA Thermo Scientific HERAfreeze Ultra Low Temperature Freezer HDE60086MA, HDE60086MD, HDE60086MV Thermo Scientific Blood Bank Refrigerators TSX5004BY, TSX5004BZ Thermo Scientific Blood Bank Refrigerators TSX3004BA, TSX3004BD, TSX3004BV Thermo Scientific CryoMed TSCM48MA (CryoMed MD 48L w/o print 120v) Thermo Scientific CryoMed TSCM48EA (CryoMed MD 48L w/ print 120v) Thermo Scientific HERAFreeze Freezers HDE30086LA Thermo Scientific Forma FDE Series -40 C Ultra-Low Temperature Freezers FDE50040LA, FDE50040LD, FDE50040LV Thermo Scientific Revco Ultra Low Temperature Freezer RDE60086MA, RDE60086MD, RDE60086MV Thermo Scientific Blood Bank Refrigerators TSX2304BY, TSX2304BZ Thermo Scientific Ultra Low Temperature Freezer TDE60086MA,TDE60086MD, TDE60086MV Thermo Scientific Plasma Freezer TSX1230LV, TSX1230LY, TSX1230LZ Thermo Scientific HERAFreeze Freezers HDE40086LA Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC06386LV Fisherbrand Isotemp Ultra-Low-Temperature Freezers IUE40086LA, IUE40086LD, IUE40086LV Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC39686LA Thermo Scientific CryoMed TSCM17MA (CryoMed MD 17L w/o print 120v) Thermo Scientific Plasma Freezer TSX2330LV, TSX2330LY, TSX2330LZ Thermo Scientific HERAFreeze Freezers HDE50086LA Thermo Scientific Revco Freezers RDE50086LA, RDE50086LD, RDE50086LV, RDE60086LA, RDE60086LD, RDE60086LV Thermo Scientific Jewett Blood Bank Refrigerator JBB404A, JBB404D, JBB404V, JBB404W Thermo Scientific CryoMed TSCM34EV (CryoMed MD 34L w/ print 230v) Ultra-Low Temperature Freezer TDEC39686LD Thermo Scientific TSX Series High-Performance Blood Bank Refrigerator TSX5004BA, TSX5004BD, TSX5004BV Thermo Scientific Revco Blood Bank Refrigerator REB404D, REB404V, REB404W Thermo Scientific CryoMed TSCM48CA (CRF CTS MD 48L w/o print 120V) Thermo Scientific TSX Series High-Performance Plasma Freezer TSX2330LA, TSX2330LD Thermo Scientific HERAFreeze Freezers HDE30086LD, HDE30086LV, HDE40086LD, HDE40086LV, Thermo Scientific CryoMed TSCM34MV (CryoMed MD 34L w/o print 230v) Thermo Scientific Revco Blood Bank Refrigerator REB5004A, REB5004D, REB5004V, REB5004W Thermo Scientific Plasma Blast Freezer XBF40D-MD Fisherbrand Isotemp Ultra-Low-Temperature Freezers IUE50086LA, IUE50086LD, IUE50086LV Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC39686LD Thermo Scientific Plasma Freezer TSX5030LV, TSX5030LY, TSX5030LZ Thermo Scientific CryoMed TSCM17TA (CRF CTS MD 17L w/print 120V) Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC06386LA Thermo Scientific Forma Freezers FDE50086LA, FDE50086LD, FDE50086LV, FDE60086LA, FDE60086LD, FDE60086LV Thermo Scientific TSX Universal Series ULT Freezer TSX50086LA Thermo Scientific TSX Universal Series ULT Freezer TSX40086LA

Establishment Types

Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198