FDA.reportPublic FDA data

Coleman

Primary DI
00368093000087
Brand
Coleman
Company
WISCONSIN PHARMACAL COMPANY, LLC
Model
7609
Device description
Coleman Waterproof First Aid Kit
Published
2023-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LRRFirst Aid Kit With Drug

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00368093000087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00368093000087003680930000873680930000870368093000087

GMDN Terms#

Term, Definition table
TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
800873986
Device count
1
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00311917042718Walgreens Personal Lubricant Moisturizer8390372024-09-30
00368093000070Coleman76052023-11-02
00368093000032CVS Pharmacy63802023-06-08
00368093000049vH Essentials12023-06-08
00368093000056CVS Pharmacy6732023-06-08
00368093000063Walgreens8002912023-06-08
00368093000001AllerBlock-Adult42102020-09-01
00368093000025Allerblock- Travel42122020-09-01
10368093000008AllerBlock-Adult42102020-09-01
10368093000022Allerblock- Travel42122020-09-01

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