FDA.reportPublic FDA data

BIOS Living

Primary DI
20057475700052
Brand
BIOS Living
Company
Thermor Ltd
Model
70005
Device description
Men's Compression Trouser Socks, Black, Large, 20-30 mmHg
Published
2023-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
10057475700055PackageGS18In Commercial Distribution
20057475700052PackageGS13In Commercial Distribution
00057475700058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005747570005510057475700055
2005747570005220057475700052
00057475700058000574757000580574757000580057475700058

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
246883458
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
07613378196157862W-CUSTOM ECF2 AGT WaistAttachment UNI °° BlackSIGVARIS INCFQL2026-05-18
07613378196164862T-CUSTOM ECF2 AG SoftTop UNI °° BlackSIGVARIS INCFQL2026-05-18
07613378196553862T-CUSTOM ECF2 AG SoftTop UNI BlackSIGVARIS INCFQL2026-05-18
07613378196560862N-CUSTOM ECF2 AG SensinovaUnisex UNI BlackSIGVARIS INCFQL2026-05-18
07613378196942862T-CUSTOM ECF2 AG SoftTop UNI °° CaramelSIGVARIS INCFQL2026-05-18
07613378197338862T-CUSTOM ECF2 AG SoftTop UNI CaramelSIGVARIS INCFQL2026-05-18
07613378197345862N-CUSTOM ECF2 AG SensinovaUnisex UNI CaramelSIGVARIS INCFQL2026-05-18
07613378197727862T-CUSTOM ECF2 AG SoftTop UNI °° GreySIGVARIS INCFQL2026-05-18
07613378198113862T-CUSTOM ECF2 AG SoftTop UNI GreySIGVARIS INCFQL2026-05-18
07613378198120862N-CUSTOM ECF2 AG SensinovaUnisex UNI GreySIGVARIS INCFQL2026-05-18
07613378198502862T-CUSTOM ECF2 AG SoftTop UNI °° SavannaSIGVARIS INCFQL2026-05-18
07613378198892862T-CUSTOM ECF2 AG SoftTop UNI SavannaSIGVARIS INCFQL2026-05-18
07613378198908862N-CUSTOM ECF2 AG SensinovaUnisex UNI SavannaSIGVARIS INCFQL2026-05-18
07613378199288862T-CUSTOM ECF2 AG SoftTop UNI °° SkinSIGVARIS INCFQL2026-05-18
07613378199677862T-CUSTOM ECF2 AG SoftTop UNI SkinSIGVARIS INCFQL2026-05-18
07613378199684862N-CUSTOM ECF2 AG SensinovaUnisex UNI SkinSIGVARIS INCFQL2026-05-18
07613378277504862N-CUSTOM ECF2 AG SensinovaUnisex UNI marineSIGVARIS INCFQL2026-05-18
07613378277511862T-CUSTOM ECF2 AG SoftTop UNI marineSIGVARIS INCFQL2026-05-18
07613378277900862T-CUSTOM ECF2 AG SoftTop UNI °° marineSIGVARIS INCFQL2026-05-18
08300496033981SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496071099SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496073109SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496073116SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496073123SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496073130SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496073147SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
07613378199295862N-CUSTOM ECF2 AG SensinovaUnisex UNI °° SkinSIGVARIS INCFQL2026-03-25
07613378196195862T-CUSTOM ECF2 AF SoftTop UNI °° BlackSIGVARIS INCFQL2026-03-18
07613378196584862T-CUSTOM ECF2 AF SoftTop UNI BlackSIGVARIS INCFQL2026-03-18
07613378196591862N-CUSTOM ECF2 AF SensinovaUnisex UNI BlackSIGVARIS INCFQL2026-03-18