FDA.reportPublic FDA data

BIOS Living

Primary DI
20057475700359
Brand
BIOS Living
Company
Thermor Ltd
Model
70035
Device description
Diabetic Socks, Beige, Medium
Published
2023-11-08
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
10057475700352PackageGS18In Commercial Distribution
20057475700359PackageGS13In Commercial Distribution
00057475700355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005747570035210057475700352
2005747570035920057475700359
00057475700355000574757003550574757003550057475700355

GMDN Terms#

Term, Definition table
TermDefinition
Antimicrobial sockA tubular, fabric device intended to be worn on the feet of a patient to help maintain foot health and reduce the growth of fungi and bacteria through inclusion of an antimicrobial agent [e.g., pure cotton yarn containing silver (Ag) nanoparticles]. It is typically indicated for a patient who suffers from athlete’s foot, diabetic foot, neurological sensory disorders (e.g., unable to feel micro traumas, touch, or temperature), and impaired blood circulation; it is generally intended to reduce the risk of primary and secondary infection. The device is normally available for daily use in the home or healthcare facility. 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
00057475000561BIOS Living59056L2023-03-31
00057475000578BIOS Living59057L2023-03-31
00057475000585BIOS Living59058L2023-03-31
00057475032500BIOS DiagnosticsW2502026-01-19
00057475160517BIOS DiagnosticsNS1602024-06-17
00057475210175BIOS LivingLK0172023-09-15
00057475210182BIOS LivingLK0182023-09-15
00057475210229BIOS LivingLK0222023-09-18
00057475210427BIOS LivingLK0422023-03-31
00057475210434BIOS LivingLK0432023-03-31
00057475210441BIOS LivingLK0442023-03-31
00057475210458BIOS LivingLK0452023-03-31
00057475210465BIOS LivingLK0462023-03-31
00057475210472BIOS LivingLK0472023-03-31
00057475210489BIOS LivingLK0482023-03-31
00057475211301BIOS LivingLK1302023-09-18
00057475220495BIOS Diagnostics220DI2023-09-20
00057475239497BIOS239DI2023-05-23
00057475242015BIOSBD2012022-03-04
00057475242404BIOSBD2402022-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613378196126862P-CUSTOM ECF2 AT1L SoftTop FEM °° BlackSIGVARIS INCFQL2026-07-22
07613378196522862P-CUSTOM ECF2 AT SoftTop MEN BlackSIGVARIS INCFQL2026-07-22
07613378196911862P-CUSTOM ECF2 AT SoftTop MEN °° CaramelSIGVARIS INCFQL2026-07-22
07613378197307862P-CUSTOM ECF2 AT SoftTop MEN CaramelSIGVARIS INCFQL2026-07-22
07613378197697862P-CUSTOM ECF2 AT SoftTop MEN °° GreySIGVARIS INCFQL2026-07-22
07613378198083862P-CUSTOM ECF2 AT SoftTop MEN GreySIGVARIS INCFQL2026-07-22
07613378198472862P-CUSTOM ECF2 AT SoftTop MEN °° SavannaSIGVARIS INCFQL2026-07-22
07613378198861862P-CUSTOM ECF2 AT SoftTop MEN SavannaSIGVARIS INCFQL2026-07-22
07613378199257862P-CUSTOM ECF2 AT SoftTop MEN °° SkinSIGVARIS INCFQL2026-07-22
07613378199646862P-CUSTOM ECF2 AT SoftTop MEN SkinSIGVARIS INCFQL2026-07-22
07613378277542862P-CUSTOM ECF2 AT SoftTop MEN marineSIGVARIS INCFQL2026-07-22
07613378277931862P-CUSTOM ECF2 AT SoftTop MEN °° marineSIGVARIS INCFQL2026-07-22
07613378196133862P-CUSTOM ECF2 AT SoftTop MEN °° BlackSIGVARIS INCFQL2026-07-20
07613378196539862P-CUSTOM ECF2 AT SoftTop FEM BlackSIGVARIS INCFQL2026-07-20
07613378196928862P-CUSTOM ECF2 AT SoftTop FEM °° CaramelSIGVARIS INCFQL2026-07-20
07613378197314862P-CUSTOM ECF2 AT SoftTop FEM CaramelSIGVARIS INCFQL2026-07-20
07613378197703862P-CUSTOM ECF2 AT SoftTop FEM °° GreySIGVARIS INCFQL2026-07-20
07613378198090862P-CUSTOM ECF2 AT SoftTop FEM GreySIGVARIS INCFQL2026-07-20
07613378198489862P-CUSTOM ECF2 AT SoftTop FEM °° SavannaSIGVARIS INCFQL2026-07-20
07613378198878862P-CUSTOM ECF2 AT SoftTop FEM SavannaSIGVARIS INCFQL2026-07-20
07613378199264862P-CUSTOM ECF2 AT SoftTop FEM °° SkinSIGVARIS INCFQL2026-07-20
07613378199653862P-CUSTOM ECF2 AT SoftTop FEM SkinSIGVARIS INCFQL2026-07-20
07613378277535862P-CUSTOM ECF2 AT SoftTop FEM marineSIGVARIS INCFQL2026-07-20
07613378277924862P-CUSTOM ECF2 AT SoftTop FEM °° marineSIGVARIS INCFQL2026-07-20
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