FDA.reportPublic FDA data

BIOS Living

Primary DI
00057475700232
Brand
BIOS Living
Company
Thermor Ltd
Model
70023
Device description
Women's Compression Hose, Black, Medium, 20-30mmHg
Published
2023-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FQLStocking, Medical Support (For General Medical Purposes)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQLStocking, Medical Support (For General Medical Purposes)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10057475700239PackageGS18In Commercial Distribution
20057475700236PackageGS13In Commercial Distribution
00057475700232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005747570023910057475700239
2005747570023620057475700236
00057475700232000574757002320574757002320057475700232

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure sock/stocking, reusableA garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is intended for use in the home or a clinical setting. This is a reusable device.

Regulatory Flags#

DUNS number
246883458
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00057475032500BIOS DiagnosticsW2502026-01-19
00057475491505BIOS DiagnosticsNS1502026-01-19
20057475032504BIOS DiagnosticsW2502026-01-19
00057475242909BIOS DiagnosticsBD2902026-01-19
10057475491502BIOS DiagnosticsNS1502026-01-19
00057475820213BIOS LivingRL0212026-01-19
00057475220495BIOS Diagnostics220DI2023-09-20
00057475282493BIOS282DI2023-05-23
00057475282738BIOS LivingLH2732024-03-21
00057475282745BIOS LivingLH2742024-03-21
00057475561017BIOS LivingEP1012024-03-22
00057475561024BIOS LivingEP1022024-03-22
00057475561031BIOS LivingEP1032024-03-23
00057475561048BIOS LivingEP1042024-03-23
00057475561055BIOS LivingEP1052024-03-22
00057475561062BIOS LivingEP1062024-03-22
00057475561079BIOS LivingEP1072024-03-22
00057475561086BIOS LivingEP1082024-03-22
00057475561093BIOS LivingEP1092024-03-22
00057475561222BIOS LivingEP1222024-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G4200211Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201011Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201021Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201031Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201041Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201061Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4202011Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4202021Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203001Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203011Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203021Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203031Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203041Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203051Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203061Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203071Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203081Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203091Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203311Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203321Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203331Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203341Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203361Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203371Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203381Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203391Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203411Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203421Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4204001Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4204011Compression StockingGottfried Medical, Inc.FQL2026-06-04