{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-03", "results": { "skip": 0, "limit": 1, "total": 9 } }, "results": [ { "proprietary_name": [ "Thermo Scientific™ TSX™ Core Series Ultra-Low Temperature Freezer TSX50086MA", "Thermo Scientific ™ CryoMed™ TSCM17TA (CRF CTS MD 17L w/print 120V)", "Thermo Scientific™ CryoMed™ TSCM34EA (CryoMed MD 34L w/ print 120v)", "Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC06386LA", "Thermo Scientific Forma Blood Bank Refrigerator FRBB3004A, FRBB3004D, FRBB3004V, FRBB3004W", "Thermo Scientific™ CryoMed™ TSCM34EV (CryoMed MD 34L w/ print 230v)", "Thermo Scientific Blood Bank Refrigerators TSX2304BY, TSX2304BZ", "Thermo Scientific Freezers TDE50086LA, TDE50086LD, TDE50086LV, TDE60086LA, TDE60086LD, TDE60086LV", "Thermo Scientific Ultra Low Temperature Freezer TDE60086MA,TDE60086MD, TDE60086MV", "Thermo Scientific™ CryoMed™ TSCM34ML (CryoMed MD 34L w/o print 100v)", "Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC25286LD", "Thermo Scientific™ CryoMed™ TSCM48MV (CryoMed MD 48L w/o print 230v)", "Thermo Scientific TSX Series High-Performance Plasma Freezer TSX3030LA, TSX3030LD", "HERAfreeze HDE Series -40 C Ultra-Low Temperature Freezers HDE50040LA, HDE50040LD,HDE50040LV", "Thermo Scientific Revco Freezers RDE50086LA, RDE50086LD, RDE50086LV, RDE60086LA, RDE60086LD, RDE60086LV", "Thermo Scientific Jewett Blood Bank Refrigerator JBB404A, JBB404D, JBB404V, JBB404W", "Thermo Scientific ™ CryoMed™ TSCM48CA (CRF CTS MD 48L w/o print 120V)", "Thermo Scientific™ CryoMed™ TSCM48EA (CryoMed MD 48L w/ print 120v)", "Thermo Scientific TSX Series High-Performance Plasma Freezer TSX2330LA, TSX2330LD", "Thermo Scientific™ CryoMed™ TSCM34MA (CryoMed MD 34L w/o print 120v)", "Thermo Scientific™ CryoMed™ TSCM17EL (CryoMed MD 17L w/ print 100v)", "Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC39686LA", "Thermo Scientific Plasma Freezer TSX3030LV, TSX3030LY, TSX3030LZ", "Ultra-Low Temperature Freezer TDEC25286LV", "Thermo Scientific HERAFreeze Freezers HDE50086LD, HDE50086LV, HDE60086LD, HDE60086LV", "Thermo Scientific Revco Blood Bank Refrigerator REB2304A, REB2304D, REB2304V, REB2304W", "Fisherbrand Isotemp Ultra-Low-Temperature Freezers IUE30086LA, IUE30086LD, IUE30086LV", "Thermo Scientific Jewett Blood Bank Refrigerator JBB3004A, JBB3004D, JBB3004V, JBB3004W", "VWR Series Chest Ultra-Low Temperature Freezer VWRC25286LA", "Thermo Scientific Revco RDE Series -40 C Ultra-Low Temperature Freezers RDE40040LA, RDE40040LD, RDE40040LV", "Thermo Scientific ™ CryoMed™ TSCM34CA (CRF CTS MD 34L w/o print 120V)", "Thermo Scientific Forma Blood Bank Refrigerator FRBB2304A, FRBB2304D, FRBB2304V, FRBB2304W", "Thermo Scientific Jewett Blood Bank Refrigerator JBB5004A, JBB5004D, JBB5004V, JBB5004W", "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 Jewett Blood Bank Refrigerator BBR25D-2A", "VWR Series Chest Ultra-Low Temperature Freezer VWRC39686LD", "Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC06386LV", "Thermo Scientific Blood Bank Refrigerators TSX5004BY, TSX5004BZ", "Thermo Scientific Blood Bank Refrigerators TSX3004BA, TSX3004BD, TSX3004BV", "Thermo Scientific Forma Ultra Low Temperature Freezer FDE60086MA, FDE60086MD, FDE60086MV", "Ultra-Low Temperature Freezer TDEC39686LV", "Thermo Scientific Jewett Blood Bank Refrigerator JBB1204A, JBB1204D, JBB1204V, JBB1204W", "HERAfreeze HDE Series -40 C Ultra-Low Temperature Freezers HDE40040LA, HDE40040LD,HDE40040LV", "Thermo Scientific HERAFreeze Freezers HDE60086LA", "Thermo Scientific™ CryoMed™ TSCM17EV (CryoMed MD 17L w/ print 230v)", "Thermo Scientific Blood Bank Refrigerators TSX1204BY, TSX1204BZ", "Thermo Scientific TSX Universal Series ULT Freezer TSX70086LA", "Thermo Scientific Forma FDE Series -40 C Ultra-Low Temperature Freezers FDE60040LA, FDE60040LD, FDE60040LV", "Thermo Scientific Freezers TDE30086LA, TDE30086LD, TDE30086LV, TDE40086LA, TDE40086LD, TDE40086LV", "Thermo Scientific Forma Blood Bank Refrigerator FRBB5004A, FRBB5004D, FRBB5004V, FRBB5004W", "Thermo Scientific™ CryoMed™ TSCM48EV (CryoMed MD 48L w/ print 230v)", "Thermo Scientific Blood Bank Refrigerators TSX3004BY, TSX3004BZ", "Thermo Scientific Blood Bank Refrigerators TSX1204BA, TSX1204BD, TSX1204BV", "Ultra-Low Temperature Freezer TDEC25286LD", "Thermo Scientific HERAFreeze Freezers HDE30086LD, HDE30086LV, HDE40086LD, HDE40086LV,", "Thermo Scientific Forma FDE Series -40 C Ultra-Low Temperature Freezers FDE40040LA, FDE40040LD, FDE40040LV", "Thermo Scientific HERAFreeze Freezers HDE50086LA", "Thermo Scientific TSX Universal Series ULT Freezer TSX50086LA", "Thermo Scientific TDE Series -40 C Ultra-Low Temperature Freezers TDE50040LA, TDE50040LD, TDE50040LV", "Thermo Scientific Plasma Freezer TSX1230LV, TSX1230LY, TSX1230LZ", "Thermo Scientific HERAFreeze Freezers HDE40086LA", "Thermo Scientific™ CryoMed™ TSCM17MA (CryoMed MD 17L w/o print 120v)", "Thermo Scientific™ CryoMed™ TSCM48ML (CryoMed MD 48L w/o print 100v)", "Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC25286LV", "Thermo Scientific Plasma Freezer TSX2330LV, TSX2330LY, TSX2330LZ", "Thermo Scientific TDE Series -40 C Ultra-Low Temperature Freezers TDE60040LA, TDE60040LD, TDE60040LV", "Thermo Scientific ™ CryoMed™ TSCM17CA (CRF CTS MD 17L w/o print 120V)", "Thermo Scientific Revco Blood Bank Refrigerator REB5004A, REB5004D, REB5004V, REB5004W", "Thermo Scientific Plasma Blast Freezer XBF40D-MD", "VWR Series Chest Ultra-Low Temperature Freezer VWRC06386LA", "Fisherbrand Isotemp Ultra-Low-Temperature Freezers IUE50086LA, IUE50086LD, IUE50086LV", "Thermo Scientific™ CryoMed™ TSCM48MA (CryoMed MD 48L w/o print 120v)", "Thermo Scientific Jewett Blood Bank Refrigerator BBR55D-1B", "Thermo Scientific TSX Universal Series ULT Freezer TSX40086LA", "Ultra-Low Temperature Freezer TDEC25286LA", "Thermo Scientific Forma Freezers FDE50086LA, FDE50086LD, FDE50086LV, FDE60086LA, FDE60086LD, FDE60086LV", "Fisherbrand Isotemp Ultra-Low-Temperature Freezers IUE40086LA, IUE40086LD, IUE40086LV", "Thermo Scientific Jewett Blood Bank Refrigerator BBR55D-2A", "Thermo Scientific Revco Ultra Low Temperature Freezer RDE60086MA, RDE60086MD, RDE60086MV", "Ultra-Low Temperature Freezer TDEC39686LD", "Thermo Scientific Revco Blood Bank Refrigerator REB404D, REB404V, REB404W", "Thermo Scientific HERAfreeze Ultra Low Temperature Freezer HDE60086MA, HDE60086MD, HDE60086MV", "Thermo Scientific™ CryoMed™ TSCM17ML (CryoMed MD 17L w/o print 100v)", "Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC25286LA", "Thermo Scientific Revco Blood Bank Refrigerator REB3004A, REB3004D, REB3004V, REB3004W", "Thermo Scientific™ CryoMed™ TSCM48EL (CryoMed MD 48L w/ print 100v)", "Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC39686LV", "Thermo Scientific Forma Freezers FDE30086LA, FDE30086LD, FDE30086LV, FDE40086LA, FDE40086LD, FDE40086LV", "Thermo Scientific™ CryoMed™ TSCM17MV (CryoMed MD 17L w/o print 230v)", "Thermo Scientific TSX Series High-Performance Plasma Freezer TSX5030LA, TSX5030LD", "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 Jewett Blood Bank Refrigerator JBB2304A, JBB2304D, JBB2304V, JBB2304W", "Thermo Scientific TSX Series High-Performance Blood Bank Refrigerator TSX2304BA, TSX2304BD, TSX2304BV", "Thermo Scientific Revco RDE Series -40 C Ultra-Low Temperature Freezers RDE50040LA, RDE50040LD, RDE50040LV", "Thermo Scientific HERAFreeze Freezers HDE30086LA", "Thermo Scientific Revco Blood Bank Refrigerator REB1204D, REB1204V, REB1204W", "Thermo Scientific™ CryoMed™ TSCM34EL (CryoMed MD 34L w/ print 100v)", "Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC39686LD", "Thermo Scientific Plasma Freezer TSX5030LV, TSX5030LY, TSX5030LZ", "Fisherbrand Isotemp Ultra-Low-Temperature Freezers IUE60086LA, IUE60086LD, IUE60086LV", "Thermo Scientific™ CryoMed™ TSCM17EA (CryoMed MD 17L w/ print 120v)", "Thermo Scientific Forma Blood Bank Refrigerator FRBB1204A, FRBB1204D, FRBB1204V, FRBB1204W", "VWR Series Chest Ultra-Low Temperature Freezer VWRC25286LD", "Thermo Scientific™ CryoMed™ TSCM34MV (CryoMed MD 34L w/o print 230v)", "Thermo Scientific TSX Series High-Performance Plasma Freezer TSX1230LA, TSX1230LD", "Thermo Scientific Forma FDE Series -40 C Ultra-Low Temperature Freezers FDE50040LA, FDE50040LD, FDE50040LV", "Ultra-Low Temperature Freezer TDEC06386LA", "Thermo Scientific Revco Freezers RDE30086LA, RDE30086LD, RDE30086LV, RDE40086LA, RDE40086LD, RDE40086LV", "Thermo Scientific TSX Series High-Performance Blood Bank Refrigerator TSX5004BA, TSX5004BD, TSX5004BV", "Thermo Scientific TDE Series -40 C Ultra-Low Temperature Freezers TDE40040LA, TDE40040LD, TDE40040LV", "Thermo Scientific Forma Blood Bank Refrigerator FRBB404A, FRBB404V, FRBB404W", "VWR Series Chest Ultra-Low Temperature Freezer VWRC39686LA", "Thermo Scientific™ TSX™ Core Series Ultra-Low Temperature Freezer TSX60086MA", "Thermo Scientific TSX Universal Series ULT Freezer TSX60086LA", "Thermo Scientific™ TSX™ Core Series Ultra-Low Temperature Freezer TSX40086MA", "Thermo Scientific™ TSX™ Core Series Ultra-Low Temperature Freezer TSX70086MA" ], "establishment_type": [ "Complaint File Establishment per 21 CFR 820.198", "Manufacture Medical Device" ], "registration": { "registration_number": "1523845", "fei_number": "1523845", "status_code": "1", "initial_importer_flag": "Y", "reg_expiry_date_year": "2026", "name": "THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC", "address_line_1": "401 MILLCREEK RD.", "address_line_2": "", "city": "MARIETTA", "state_code": "OH", "iso_country_code": "US", "zip_code": "45750", "postal_code": "", "us_agent": {}, "owner_operator": { "firm_name": "THERMO FISHER SCIENTIFIC INC.", "owner_operator_number": "2182773", "official_correspondent": {}, "contact_address": { "address_1": "168 Third Avenue", "address_2": "--", "city": "Waltham", "state_code": "MA", "state_province": "", "iso_country_code": "US", "postal_code": "02451" } } }, "pma_number": "", "k_number": "", "products": [ { "product_code": "KSE", "created_date": "1992-11-04", "owner_operator_number": "2182773", "exempt": "", "openfda": { "device_name": "Refrigerator, Freezer, Blood Storage", "medical_specialty_description": "Hematology", "regulation_number": "864.9700", "device_class": "2" } } ] } ] }