FDA.reportPublic FDA data

IFAK

Primary DI
B54133311380
Brand
IFAK
Company
FARETEC, INC.
Model
IFAK 49
Catalog number
3331138
Device description
INDIVIDUAL FIRST AID KIT/CUSTOM
Published
2025-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHOFirst Aid Kit Without Drug

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B54133311380PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
First aid kit, non-medicated, single-useA convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
440-350-9510callie@faretec.com

Regulatory Flags#

DUNS number
626802540
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B54133311420IFAKUNICEF IFAK KIT33311422026-05-12
B54133311410IFAKIFAK LOT 4 33311412026-01-12
B54133311400IFAKIFAK 51 (Ind. First Aid Kit)33311402025-06-19
B54133311390IFAKIFAK 5033311392025-04-18
B54133311370IFAKIFAK 4833311372025-03-14
B54133310470IFAKCombat Casualty IFAK (DLIFAK)33310472025-02-26
B54133311360IFAKIFAK 4733311362025-01-31
B54170019070IFAKTactical Medical Kit, Backpack70019072025-01-31
B54170019080IFAKTactical Medical Bag-Component70019082025-01-31
B54133311350IFAKIFAK 4633311352024-12-11
B54133311340IFAKUN IFAK Advanced Lot 3 Plus33311342024-12-04
B54133311320IFAKIFAK Kit Advanced33311322024-06-14
B54133311310IFAKIFAK 4433311312024-06-10
B54133311300IFAKUN IFAK Advanced33311302024-05-09
B54180030080Pelvic BinderPelvic Binder, Coyote Brown80030082024-02-28
B54133311280IFAKIFAK 4333311282024-01-26
B54133311250IFAKIFAK 4033311252023-12-20
B54133311260IFAKIFAK 4133311262023-12-20
B54133311270IFAKIFAK 4233311272023-12-20
B54133311240IFAKIFAK 3933311242023-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842209140596NARNORTH AMERICAN RESCUE, LLCOHO2026-10-27
00842209140602NARNORTH AMERICAN RESCUE, LLCOHO2026-10-27
00842209140619NARNORTH AMERICAN RESCUE, LLCOHO2026-10-27
00842209140633NARNORTH AMERICAN RESCUE, LLCOHO2026-10-27
00842209140640NARNORTH AMERICAN RESCUE, LLCOHO2026-10-27
00842209140657NARNORTH AMERICAN RESCUE, LLCOHO2026-10-27
06942509220593OP - First aid seriesdata:image/svg+xml,%3csvg%20xmlns='http://www.w3.org/2000/Yiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-24
06942509220609OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-24
06942509220616OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-24
06942509220623OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-24
00850070635226Response KitNar Medical Depot, LLCOHO2026-10-23
00850070635257Response KitNar Medical Depot, LLCOHO2026-10-23
00850070635264Pro Response KitNar Medical Depot, LLCOHO2026-10-23
00850070635288Response KitNar Medical Depot, LLCOHO2026-10-23
00850070635295Response Plus kitNar Medical Depot, LLCOHO2026-10-23
00850070635318Pro Response KitNar Medical Depot, LLCOHO2026-10-23
00850070635356RESPONSE KITNar Medical Depot, LLCOHO2026-10-23
06942509220647OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
06942509220708OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
06942509220715OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
06942509220722OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
06942509220890OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
06942509221217OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
M6898723101040Bleeding Control KitSafeguard US Operating, LLCOHO2026-10-22
M68981601030Rant Strategies K9 Trauma KitSafeguard US Operating, LLCOHO2026-10-20
00842209140367NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140374NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140398NAR KitNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140404NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140411NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14