Home GUDID 00616784302119
DynaLevin Waterproof Adhesive Bordered Foam Dressing
Primary DI 00616784302119
Brand DynaLevin Waterproof Adhesive Bordered Foam Dressing
Company Dynarex Corporation
Model 3021
Device description "DynaLevin Waterproof Adhesive Bordered Foam Dressing, 4""x4"""
Published 2021-06-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true
Single use true Product Codes# Code, Name table Code Name NAC Dressing, Wound, Hydrophilic NAD Dressing, Wound, Occlusive
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NAC Dressing, Wound, Hydrophilic General, Plastic Surgery 1 NAD Dressing, Wound, Occlusive General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00616784302126 Package GS1 10 In Commercial Distribution 00616784302133 Package GS1 12 In Commercial Distribution 00616784302119 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00616784302126 00616784302126 616784302126 0616784302126 00616784302133 00616784302133 616784302133 0616784302133 00616784302119 00616784302119 616784302119 0616784302119
GMDN Terms# Term, Definition table Term Definition Negative-pressure wound therapy system foam dressing, non-antimicrobial A pad made of open-cell foam material designed to be placed into a wound during a vacuum-assisted wound closure procedure, commonly known as negative pressure wound therapy (NPWT); it does not include an antimicrobial agent(s). It is typically used to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. Under NPWT, the open-cell foam dressing decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure. It may be cut to conform to the wound. This is a single-use device.
Regulatory Flags# DUNS number 008124539 Device count 1 Premarket exempt true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00840117346307 Vital Signs Stand, Compatible with item 10843 10856 2026-06-08 00840117349544 Drape Sheets, Tissue / Poly 2-ply, Black, 40" x 90" (101.6 cm x 228.6 cm) 8150BLK 2026-06-08 00840117349568 Pillow Cases, Tissue / Poly 2-ply, Black, 21" x 30" (53.3 cm x 76.2 cm) 8161BLK 2026-06-08 00840117327610 Titan-700 Bariatric Rollator 10217 2023-12-28 00840117325968 Platform Attachment 10212 2023-03-24 00840117326026 Dynarex Bari + Max Bariatric Platform Attachment 10213 2023-03-24 00616784020419 Vivid-Flex, Adjustable Height Rollator 10204 2019-10-07 00616784021515 Compact Steerable Knee Walker, With Basket, Steel 10215 2019-10-08 00616784021614 Steerable Knee Walker with Basket 10216 2019-10-08 00616784020815 DynaGo Duo Transport Rollator With 7.5" Casters and Plastic Footrest 10208 2019-11-13 00840117325913 Bari + Max Bariatric HD Steel Walker, Weight Capacity 700 lb. 10169 2023-01-09 00840117336483 Steel Button Folding Walker with 5 Wheels, Adults 10170 2024-06-17 00616784020013 DynaGo Zoom - Aluminum Rollator with 3" Wheels 10200 2019-10-07 00616784020112 Vivid-Quad, Rollator, With 6" Caster , Blue 10201BL 2019-10-07 00616784020211 Vivid-Terrain, Rollator with 7.5" Caster 10202 2019-10-07 00616784020310 Titan-500 Bariatric Rollator 10203 2019-10-07 00616784020129 Vivid-Quad, Rollator, With 6" Caster, Red 10201RD 2019-11-07 00616784020136 Vivid-Quad, Rollator, With 6" Caster, Black 10201BK 2019-11-07 00616784020143 Vivid-Quad, Rollator, With 6" Caster, Pink 10201PK 2019-11-07 00616784016016 DMECare Solutions Two Button Folding Walker, Adult (32"-39") 10160 2019-10-01
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