FDA.reportPublic FDA data

Heat Stress - 16 Poly White

Primary DI
00766588247045
Brand
Heat Stress - 16 Poly White
Company
Certified Safety Manufacturing, Inc.
Model
K624-904
Catalog number
K624-904
Device description
Heat Stress - 16 Poly White
Published
2025-03-24
Public version status
Update
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
LRRFirst Aid Kit with drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRRFirst Aid Kit With DrugUnknownN

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K940249000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940249000CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSINGCertified Safety Mfg., Inc.1994-10-03LRR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00766588247045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00766588247045007665882470457665882470450766588247045

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

Contacts#

Phone, Email table
PhoneEmail
+1(816)483-9090Info@certifiedsafety.com

Regulatory Flags#

DUNS number
788460483
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00766588260143Watercraft First Aid Kit - 16 Poly WhiteK626-014K626-0142026-08-19
00766588260181Teichert Clas A 21 - 18 MetalK626-018K626-0182026-08-19
00766588260112Class A 21 - Grab-N-Go Large - Red Velcro BagK626-011K626-0112026-06-04
00766588283463Cohesive Wrap - 2"x 5 ydsR228-346R228-3462026-06-04
10766588283460Cohesive Wrap - 2"x 5 yds - UDI/10R228-346R228-3462026-06-04
00766588260037Naloxone - 16 Poly ClearK626-003K626-0032026-05-26
00766588420103Forceps - MagnifierR242-010R242-0102026-05-26
10766588420100Forceps - Magnifier UDI/10R242-010R242-0102026-05-26
00766588260099Cement Burn Cabinet - 75H 2 Shelf CabinetK626-009K626-0092026-05-04
00766588090177FAA SWA on Board PPE Bag - ZLBFK209-017FK209-0172026-04-29
00766588090160FAA SWA BioHazard Clean Up Bag - ZLBFK209-016FK209-0162026-04-16
00766588260044Class B 21 BloodBorne Pathogen - 75H CabinetK626-004K626-0042026-04-16
00766588260075So Cal Gas Wilderness Tactical Class B 21 - Jump Bag 5210K626-007K626-0072026-04-16
00766588260020Naloxone - 10 Poly WhiteK626-002K626-0022026-04-06
00766588260068Burn Dressing Large - Red Velcro BagK626-006K626-0062026-04-06
00766588260051Burn Dressing Small - Red Velcro BagK626-005K626-0052026-03-23
00766588127675RR - UP Vehicle - 75 RefillKR612-067KR612-0672026-03-02
00766588249810Class B 21 ANSI Plus - RTB 5186K624-981K624-9812026-03-02
0076658825009050 Person Contractors Kit - 24 Poly WhiteK625-009K625-0092026-03-02
00766588235714"607 QF Strips Plastic 1""x 3"" 16/Box"R523-571R523-5712026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942509220548OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220555OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220562OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220579OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220630OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220654OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220661OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220678OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220739OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220753OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220760OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220777OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220784OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220807OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220814OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220821OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220838OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220845OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220852OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220869OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220876OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220883OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220920OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220937OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
00766588260143Watercraft First Aid Kit - 16 Poly WhiteCertified Safety Manufacturing, Inc.LRR2026-08-19
00766588260181Teichert Clas A 21 - 18 MetalCertified Safety Manufacturing, Inc.LRR2026-08-19
00842209139682NARNORTH AMERICAN RESCUE, LLCLRR2026-08-19
00842209139699NARNORTH AMERICAN RESCUE, LLCLRR2026-08-19
00842209139712NARNORTH AMERICAN RESCUE, LLCLRR2026-08-19
00842209139729NARNORTH AMERICAN RESCUE, LLCLRR2026-08-19