FDA.reportPublic FDA data

Mediwash Antimicrobial Rx Irrigation Solution 946 mL Pour Bottle

Primary DI
00850074049050
Brand
Mediwash Antimicrobial Rx Irrigation Solution 946 mL Pour Bottle
Company
Accelerate Pharmaceutical LLC
Model
25.06
Catalog number
MEDI-946-USA
Device description
946 mL bottle of 0.02% Hypochlorous Acid (HOCI) for Irrigation. 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
Single use
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
00850074049050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850074049050008500740490508500740490500850074049050

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 Volume32Fluid Ounce
Total Volume946Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature68 Degrees Fahrenheit77 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
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
00850074049111Mediwash Antimicrobial Rx Advanced Skin & Wound Solution, 237 mL25.12MEDI-237X-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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