FDA.reportPublic FDA data

BE SMART GET PREPARED

Primary DI
00020424210618
Brand
BE SMART GET PREPARED
Company
TOTAL RESOURCES INTERNATIONAL INC.
Model
04HBC21061BOX
Catalog number
657189531
Device description
SILVEX ® Antibacterial Nano Silver Wound Wash by Be Smart Get Prepared, 4 oz – Treats Minor Cuts, Abrasions, Lacerations, Sunburns, 1st & 2nd Degree Burns, Skin Irritations, Diabetic Ulcers, Pressure Ulcers, & Post-Surgical Wounds - (1) SILVEX® Silver Wound Wash [4 oz]
Published
2024-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151185000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151185000AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC)Abl Medical, LLC2016-02-05FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00020424210618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00020424210618000204242106180204242106180020424210618

GMDN Terms#

Term, Definition table
TermDefinition
Antimicrobial wound irrigation solutionA solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridement and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight113.398093Gram

Contacts#

Phone, Email table
PhoneEmail
8887717824info@trikits.com
9095941220junb@trikits.com
9095941220dennisn@trikits.com
9095941220ederlyne@trikits.com

Regulatory Flags#

DUNS number
790160535
Device count
1
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
00020424221249BE SMART GET PREPARED22EME06124CC; 22EME06124CCPLTQTR2026-04-21
20020424226811BE SMART GET PREPARED22EME06081NEWPLT2026-04-02
00020424010157BE SMART GET PREPARED20HBC01015REV5X004BQ2VVL2026-03-31
00020424016432ESSENTIALS16LOW0164312504542026-03-27
00020424100087Be Smart Get Prepared10COM15008REV12025-11-24
00020424060770BE SMART GET PREPARED22EME06077; 22EME06077A2025-11-21
00020424201159BE SMART GET PREPARED20HBC01015CCREV3; 20HBC01015CCREV4; 20HBC01015REV4X0013DSLAP2024-01-09
00020424220815BE SMART GET PREPARED22EME06081NEWCC2025-03-05
00781002848950L.H. Dottie16DOT01405CS2025-02-25
00020424210083BE SMART GET PREPARED03HBC21073PK82025-01-24
00020424101824BE SMART GET PREPARED10HBC01082REV1A2025-01-10
00020424150075BE SMART GET PREPARED10COM15007REV22025-01-10
00020424014025Be Smart Get Prepared10HBC014022025-01-09
00020424211745Be Smart Get Prepared03HBC211742025-01-09
00020424211851Be Smart Get Prepared03HBC211852025-01-09
00020424060879BE SMART GET PREPARED22EME06087REV1; 22EME06087REV22024-01-05
00020424013639BE SMART GET PREPARED10COM01363; 10HBC01363; 10HBC01363RECOMX0044NVFNL2024-01-12
00020424021429BE SMART GET PREPARED10OUT02142; 10OUT02142REV12024-01-05
00020424080013BE SMART GET PREPARED00-GAU-8001YOU00-GAU-8001YOU2024-12-13
00020424199975Be Smart Get Prepared19-NAS-04997CS2024-12-10

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