FDA.reportPublic FDA data

BrightCare

Primary DI
00856614007887
Brand
BrightCare
Company
The Gilbert Group LLC
Model
SQ1222
Published
2025-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LRRFirst Aid Kit With Drug
OHOFirst Aid Kit Without Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRRFirst Aid Kit With DrugUnknownN
OHOFirst Aid Kit Without DrugGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856614007887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856614007887008566140078878566140078870856614007887

GMDN Terms#

Term, Definition table
TermDefinition
First aid kit, medicatedA convenient collection of equipment, materials and pharmaceuticals intended to be used in an emergency for the rapid, initial treatment of an injury. It is typically used by emergency medical services (EMS), hospitals, institutions, schools, and other public settings. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
075007395
Device count
1
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856614007863BrightCareSQ12202025-12-02
00856614007870BrightCareSQ12212025-12-02
00856614007757BrightCareSQ12092024-08-29
00856614007764BrightCareSQ12102024-08-29
00856614007771BrightCareSQ12112024-08-29
00856614007788BrightCareSQ12122024-08-29
00856614007795BrightCareSQ12132024-08-29
00856614007801BrightCareSQ12142024-08-29
00856614007818BrightCareSQ12152024-08-29
00856614007825BrightCareSQ12162024-08-29
00856614007832BrightCareSQ12172024-08-29
00852272007184BrightCare MedsoftSQ10432023-08-24
00852272007238BrightCare MedsoftSQ10482023-09-02
00852272007481BrightCareSQ10722023-09-02
00852272007504BrightCareSQ10742023-09-02
00852272007528BrightCareSQ10762023-09-02
00852272007542BrightCareSQ10782023-09-02
00852272007801BrightCareSQ11042023-09-02
00852272007825BrightCareSQ11062023-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00050428000021CVS Health WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLRR2026-05-19
B54133311420IFAKFARETEC, INC.OHO2026-05-12
50842209110662NARNORTH AMERICAN RESCUE, LLCOHO2026-05-11
M6898130301130MARCH IFAK RESUPPLYSafeguard US Operating, LLCOHO2026-05-05
00092265917841First Aid OnlyAcme United CorporationLRR2026-04-23
00020424221249BE SMART GET PREPAREDTOTAL RESOURCES INTERNATIONAL INC.LRR2026-04-21
M6898141003030Maritime First Aid Resupply - AdvancedSafeguard US Operating, LLCOHO2026-04-07
10850015055826Trauma KitULINE, INC.LRR2026-04-06
M689WJBBC4010Bleeding Control Kit Plus 6/cs Safeguard US Operating, LLCOHO2026-04-02
20020424226811BE SMART GET PREPAREDTOTAL RESOURCES INTERNATIONAL INC.LRR2026-04-02
00020424010157BE SMART GET PREPAREDTOTAL RESOURCES INTERNATIONAL INC.LRR2026-03-31
00020424016432ESSENTIALSTOTAL RESOURCES INTERNATIONAL INC.LRR2026-03-27
00017276241334Bluey First Aid KitAso LLCLRR2026-03-03
M6898113201100Mojo IFAK - BasicSafeguard US Operating, LLCOHO2026-02-19
00197344173627CURADMEDLINE INDUSTRIES, INC.LRR2026-01-23
B54133311410IFAKFARETEC, INC.OHO2026-01-12
00020424060770BE SMART GET PREPAREDTOTAL RESOURCES INTERNATIONAL INC.LRR2025-11-21
00017276240931up&upTARGET CORPORATIONLRR2025-11-03
M68983323100Mojo Combat Lifesaver Bag - IntermediateSafeguard US Operating, LLCOHO2025-10-27
00197344131610CURADMEDLINE INDUSTRIES, INC.OHO2025-10-17
M689SHTPKSM040Trauma PackSafeguard US Operating, LLCOHO2025-10-16
M689SHTPKTMTSM040TRAUMA BLEED CONTROL INDIV.Safeguard US Operating, LLCOHO2025-10-16
M68924105050Poolside Medical Rescue RefillSafeguard US Operating, LLCLRR2025-10-14
00092265960021First Aid OnlyAcme United CorporationLRR2025-09-30
00193489100351CURADMEDLINE INDUSTRIES, INC.LRR2025-06-02
00096295144857LEADERCardinal Health 110, Inc.LRR2025-05-13
M68984497110Mojo Direct Action - AdvancedSafeguard US Operating, LLCOHO2025-04-10
M6898332401140Mojo Combat Lifesaver Bag - BasicSafeguard US Operating, LLCOHO2025-03-26
00017276240184Crayola First Aid KitAso LLCLRR2025-02-10
00050428103623CVS Health WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLRR2024-09-17