FDA.reportPublic FDA data

Safety General Purpose - 10 Poly White

Primary DI
00766588250076
Brand
Safety General Purpose - 10 Poly White
Company
Certified Safety Manufacturing, Inc.
Model
K625-007
Catalog number
K625-007
Device description
Safety General Purpose - 10 Poly White
Published
2025-12-18
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
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
00766588250076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00766588250076007665882500767665882500760766588250076

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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00766588247045Heat Stress - 16 Poly WhiteK624-904K624-9042025-03-24
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
00766588235998QF C-Protector Mouth-to-Mouth BarrierR523-599R523-5992026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00766588260112Class A 21 - Grab-N-Go Large - Red Velcro BagCertified Safety Manufacturing, Inc.LRR2026-06-04
00888277719081RexallMEDLINE INDUSTRIES, INC.LRR2026-06-03
00842209138890NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138906NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138913NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138920NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138944NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138951NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00050428000021CVS Health WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLRR2026-05-19
00092265917841First Aid OnlyAcme United CorporationLRR2026-04-23
00020424221249BE SMART GET PREPAREDTOTAL RESOURCES INTERNATIONAL INC.LRR2026-04-21
00713733293129MEIJERMEIJER, INC.LRR2026-04-20
00760236195603MeijerMEIJER, INC.LRR2026-04-20
00666365119704NanukNanuk Gear Protection USA Inc.LRR2026-04-16
10850015055826Trauma KitULINE, INC.LRR2026-04-06
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
00197344173627CURADMEDLINE INDUSTRIES, INC.LRR2026-01-23
00020424060770BE SMART GET PREPAREDTOTAL RESOURCES INTERNATIONAL INC.LRR2025-11-21
00017276240931up&upTARGET CORPORATIONLRR2025-11-03
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
00017276240184Crayola First Aid KitAso LLCLRR2025-02-10
00050428103623CVS Health WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLRR2024-09-17
00193489081766CURADMEDLINE INDUSTRIES, INC.LRR2024-08-06
00017276237542Care Science Aso LLCLRR2024-07-08