FDA.reportPublic FDA data

BIOS Living

Primary DI
10057475541016
Brand
BIOS Living
Company
Thermor Ltd
Model
ED101
Device description
Lightweight Utensils (5 piece set)
Published
2024-03-21
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
ILCUtensil, Eating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILCUtensil, EatingPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10057475541016PackageGS124In Commercial Distribution
00057475541019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005747554101610057475541016
00057475541019000574755410190574755410190057475541019

GMDN Terms#

Term, Definition table
TermDefinition
Assistive cutleryA device designed as an eating utensil (e.g., a specialized knife, spoon, or fork) used by a person with a disability to cut food and/or to transfer food into their mouth. 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
true
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
00810226441217ViveVIVE HEALTH LLCILC2026-07-21
00810226440104ViveVIVE HEALTH LLCILC2026-06-04
00810226440111ViveVIVE HEALTH LLCILC2026-06-04
00661392008076LSL HEALTHCARELSL Industries, LLCILC2025-05-15
10661392008073LSL HEALTHCARELSL Industries, LLCILC2025-05-15
00057475541019BIOS LivingThermor LtdILC2024-03-21
00023601035073CarexDrive Devilbiss HealthcareILC2023-12-07
30023601035074CarexCOMPASS HEALTH BRANDS CORP.ILC2023-12-07
00194346098057EQUATEDrive Devilbiss HealthcareILC2023-08-04
30194346098058EQUATECOMPASS HEALTH BRANDS CORP.ILC2023-08-04
00859911004825SafeStrawBionix, LLCILC2023-07-19
00859911004832SafeStrawBionix, LLCILC2023-07-19
10859911004822SafeStrawBionix, LLCILC2023-07-19
10859911004839SafeStrawBionix, LLCILC2023-07-19
10686864048777SOLONAMD Medicom IncILC2023-07-10
10686864048821AMD-RITMED SOLONAMD Medicom IncILC2023-07-10
20686864048774SOLONAMD Medicom IncILC2023-07-10
20686864048828AMD-RITMED SOLONAMD Medicom IncILC2023-07-10
07320450002021Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002038Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002045Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002052Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002076Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002083Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002090Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002106Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002113Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002120Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002168Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002175Etac Supply Center ABEtac Supply Center ABILC2022-12-07