FDA.reportPublic FDA data

Mediwash Antimicrobial Rx Advanced Skin & Wound Solution, 237 mL

Primary DI
00850074049111
Brand
Mediwash Antimicrobial Rx Advanced Skin & Wound Solution, 237 mL
Company
Accelerate Pharmaceutical LLC
Model
25.12
Catalog number
MEDI-237X-USA
Device description
237 mL bottle of 0.015% Hypochlorous Acid (HOCI) skin and wound solution for cleansing and debridement. To clean acute and chronic wounds, such as surgical sites, cuts, burns, ulcers, pressure sores; removing debris, bacteria, and/or biofilm while promoting a moist healing environment. Rx Only.
Published
2025-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850074049111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850074049111008500740491118500740491110850074049111

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
Total Volume8Fluid Ounce
Total Volume237Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius0 Degrees Celsius
Storage Environment Temperature32 Degrees Fahrenheit0 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
800-676-3891mediwash@acceleratepharm.com

Regulatory Flags#

DUNS number
119465541
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850074049050Mediwash Antimicrobial Rx Irrigation Solution 946 mL Pour Bottle25.06MEDI-946-USA2025-10-20
00850074049067Mediwash Antimicrobial Rx Irrigation Solution 473 mL Pour Bottle25.07MEDI-473-USA2025-10-20
00850074049074Mediwash Antimicrobial Rx Hydrogel, 59 mL25.08MEDI-59HX-USA2025-10-20
00850074049081Mediwash Antimicrobial Hydrogel, 59 mL25.09MEDI-59H-USA2025-10-20
00850074049098Mediwash Antimicrobial Rx Hydrogel, 237 mL25.10MEDI-237HX-USA2025-10-20
00850074049104Mediwash Antimicrobial Hydrogel, 237 mL25.11MEDI-237H-USA2025-10-20
00850074049128Mediwash Antimicrobial Advanced Skin & Wound Solution, 237 mL25.13MEDI-237-USA2025-10-20
00850074049135Mediwash Antimicrobial Advanced Skin & Wound Solution, 59 mL25.14MEDI-59-USA2025-10-20

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