FDA.reportPublic FDA data

Carex

Primary DI
00023601035073
Brand
Carex
Company
Drive Devilbiss Healthcare
Model
FGP50700 0000
Device description
ADAPTIVE CUTLERY SET
Published
2023-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Contact Domains#

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
30023601035074PackageGS14In Commercial Distribution
00023601035073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3002360103507430023601035074
00023601035073000236010350730236010350730023601035073

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.

Contacts#

Phone, Email table
PhoneEmail
800-376-7263CustomerService@compasshealthbrands.com

Regulatory Flags#

DUNS number
867673159
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00023601061102Carex Health BrandsFGR11000 00002016-10-07
00092237614419Roscoe MedicalHUM-ROS62018-12-19
50050428250391DRIVEMEDICAL7417372019-06-21
00311917192352Walgreens9847282019-06-21
00822383989815DRIVEMEDICAL146-RTLPC23201-M2019-06-21
00822383989839DRIVEMEDICAL146-RTLPC23201-F2019-06-21
00822383246420DriveRTLPC23201-F2017-05-19
00822383037127Silver SportBIN-SSP316DDA-SF2026-06-22
00822383037134Silver SportBIN-SSP218DDA-SF2026-06-22
00822383037141Silver SportBIN-SSP220DDA-SF2026-06-22
00822383037158Cruiser 3 16"BIN-K316ADDA-SF2026-06-22
00822383037165Cruiser 3 18"BIN-K318ADDA-SF2026-06-22
00822383037172Cruiser 3 20"BIN-K320ADDA-SF2026-06-22
00194346283439EquateEQKW5002026-06-10
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00869174000113ObiIndependent Feeding Device, LLCILC2026-08-19
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
10057475541016BIOS LivingThermor LtdILC2024-03-21
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