FDA.reportPublic FDA data

CUSTOM

Primary DI
09341394012547
Brand
CUSTOM
Company
AERO HEALTHCARE (US), LLC
Model
AKB25W-311
Catalog number
AKB25W-311
Device description
First Aid Kit
Published
2023-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
09341394012547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09341394012547093413940125479341394012547

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
008186174
Device count
1
Premarket exempt
true
Kit
true
Combination product
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09341394005242AeroShield CPR MaskAM01BUSAM01BUS2026-04-21
09341394027183AeroShield CPR Face ShieldAFS001USAFS001US2026-04-02
09341394009158SUREFILLAKP01AKP012023-12-08
09341394009172SUREFILLAKB10WAKB10W2023-12-08
09341394009189SUREFILLAKB25WAKB25W2023-12-08
09341394009196SUREFILLAKB50WAKB50W2023-12-08
09341394009219SUREFILLAK75EWNAK75EWN2023-12-08
09341394009226SUREFILLAK10TAK10T2023-12-08
09341394009264SUREFILLAK25ATAK25AT2023-12-08
09341394009288SUREFILLAK25AWAK25AW2023-12-08
09341394009295SUREFILLAK25AVAK25AV2023-12-08
09341394009301SUREFILLAK25ANRAK25ANR2023-12-08
09341394009318SUREFILLAK50ATAK50AT2023-12-08
09341394009332SUREFILLAK50AWAK50AW2023-12-08
09341394009349SUREFILLAK50AVAK50AV2023-12-08
09341394009356SUREFILLAK50ANRAK50ANR2023-12-08
09341394009387SUREFILLAK50BWAK50BW2023-12-08
09341394009400SUREFILLAK50BNRAK50BNR2023-12-08
09341394011427CUSTOMAKPEI01-282AKPEI01-2822023-12-08
09341394011434CUSTOMAKPBT01-282AKPBT01-2822023-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00041260020803KrogerKROGER CO., THELRR2024-04-15
00091966043309AAALIFELINE FIRST AID, LLCLRR2024-03-11
00020424104146BE SMART GET PREPAREDTOTAL RESOURCES INTERNATIONAL INC.LRR2024-01-10
00020424101879BE SMART GET PREPAREDTOTAL RESOURCES INTERNATIONAL INC.LRR2024-01-09
00020424101886BE SMART GET PREPAREDTOTAL RESOURCES INTERNATIONAL INC.LRR2024-01-09
00020424201159BE SMART GET PREPAREDTOTAL RESOURCES INTERNATIONAL INC.LRR2024-01-09
00661948008840GARYLINEGaryline LLCLRR2023-10-26
10612479257518McKessonMCKESSON MEDICAL-SURGICAL INC.LRR2023-09-14