FDA.reportPublic FDA data

BrightCare

Primary DI
00856614007801
Brand
BrightCare
Company
The Gilbert Group LLC
Model
SQ1214
Published
2024-08-29
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
00856614007801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856614007801008566140078018566140078010856614007801

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
00856614007887BrightCareSQ12222025-12-02
00856614007757BrightCareSQ12092024-08-29
00856614007764BrightCareSQ12102024-08-29
00856614007771BrightCareSQ12112024-08-29
00856614007788BrightCareSQ12122024-08-29
00856614007795BrightCareSQ12132024-08-29
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
00842209138760NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138777NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138784NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138791NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138807NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138814NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138821NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138838NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138845NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138852NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138869NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138876NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138883NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138890NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138906NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138913NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138920NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138937NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138944NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138951NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138968NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138975NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
M6898444601190Mojo Multi Mission - AdvancedSafeguard US Operating, LLCOHO2026-05-27
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