FDA.reportPublic FDA data

Mediwash Antimicrobial Rx Hydrogel, 237 mL

Primary DI
00850074049098
Brand
Mediwash Antimicrobial Rx Hydrogel, 237 mL
Company
Accelerate Pharmaceutical LLC
Model
25.10
Catalog number
MEDI-237HX-USA
Device description
237 mL bottle of 0.015% Hypochlorous Acid (HOCI) Hydrogel for post-operative care, management of partial & full thickness wounds, including burns. 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
00850074049098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850074049098008500740490988500740490980850074049098

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases. This is a single-use device.

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
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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