Areza Medical

Primary DI
00850021481315
Brand
Areza Medical
Company
ADVANCED MEDICAL ASSOCIATES, LLC
Model
45332
Catalog number
45332
Device description
Foam dressings are sheets of foamed polymer solutions (most commonly polyurethane) with small, open cells capable of holding fluids. They are layered in combination with other materials. Absorption capability depends on thickness and composition. The area in contact with the wound surface is non-adhesive for easy removal. Available with an adhesive border and/or a transparent film coating that acts as a bacterial barrier. Indicated for partial and full-thickness wounds.
Published
2020-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850021481315PrimaryGS10
00850021481322Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850021481315008500214813158500214813150850021481315
00850021481322008500214813228500214813220850021481322

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, non-antimicrobialA wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Inch
Width4Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dry, cool environment. Avoid excessive heat.

Contacts#

Phone, Email table
PhoneEmail
877-931-1387info@arezamedical.com

Regulatory Flags#

DUNS number
047724226
Device count
5
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850021481766Areza MedicalRT4X11RT4X112024-11-07
00810147400225Areza MedicalCOPOVV10COPOVV102024-10-26
00810147400263Areza MedicalCOPOV10COPOV102024-10-26
00810147400546Areza MedicalCMC42520CMC425202024-10-26
00850021481001Areza MedicalSSF91010 SSF91010 2024-10-26
00850021481674Areza MedicalBG8430 BG84302024-10-26
00850021481728Areza MedicalBG8630BG86302024-10-26
00850021481742Areza MedicalAGF42510AGF425102024-10-26
00850021481759Areza MedicalAGF42520AGF425202024-10-26
00850021481773Areza MedicalSA42520SA425202024-10-25
00850021481810Areza MedicalSA425100SA4251002024-10-25
00850021481902Areza MedicalF5410F54102024-10-26
00810147400232Areza MedicalCOPOVV10COPOVV102024-10-26
00810147400270Areza MedicalCOPOV10COPOV102024-10-26
00850021481957Areza MedicalSSF91010 SSF91010 2024-10-26
00810147400836Areza MedicalBG8430 BG84302024-10-26
00810147400850Areza MedicalBG8630BG86302024-10-26
00850021481865Areza MedicalAGF42510AGF425102024-10-26
00850021481827Areza MedicalAGF42520AGF425202024-10-26
00850021481841Areza MedicalSA42520SA425202024-10-25

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