FDA.reportPublic FDA data

AquaDerm Healogics by DermaRite

Primary DI
00714196930323
Brand
AquaDerm Healogics by DermaRite
Company
DERMARITE INDUSTRIES LLC
Model
93032
Published
2020-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00714196930323PrimaryGS10
01714196930322Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00714196930323007141969303237141969303230714196930323
01714196930322017141969303221714196930322

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, non-antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations 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; it does not include an antimicrobial agent(s). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
883925562
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00714196464507AquaRite Ag Extra CMC464502025-06-01
07141964666000AquaRite Ag Extra CMC466602025-06-01
00714196052629ComfortGauze Border422622025-01-08
00714196052636ComfortGauze Border422632025-01-08
71419624712486DermaSyn002472024-10-21
01714196500150SilvaKollagen Gel00500005002023-10-04
00714196390028AquaDerm00322E2022-05-02
00714196391780DermaFilm thin with Border00229E2021-09-10
00714196390004Adhesive Tape Remover Pads821002021-09-09
00714196390042AquaDerm00324E2021-09-09
00714196390066AquaRite Extra CMC40220402202021-09-09
00714196390080AquaRite Extra CMC40318403182021-09-09
00714196390103AquaRite Extra CMC404502021-09-09
00714196390127AquaRite Extra CMC406602021-09-09
00714196390141Bordered Foam 4" Round00288E2021-09-09
00714196390165Bordered Foam00297E2021-09-09
00714196390189Bordered Foam00298E2021-09-09
00714196390288Sterile Bordered Gauze112302021-09-09
00714196390301Sterile Bordered Gauze113642021-09-09
00714196390325Sterile Bordered Gauze114102021-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06975278040048vaginal intense climax liquid/pleasure gelJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040055vaginal intense climax liquid/pleasure gelJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040062vaginal intense climax liquid/pleasure gelJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040079vaginal intense climax liquid/pleasure gelJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040086vaginal pleasure liquibead/climax intense liquibeadJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040116vaginal virgin gel/tightening gel creamJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040123vaginal virgin gel/tightening gel creamJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040130vaginal virgin gel/tightening gel creamJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
00743537000449First ResponderWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
00743537000715MilitaryWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
00860000562539LaviorLavior Pharma Inc.NAE2026-02-14
00860007877766LaviorLavior Pharma Inc.NAE2026-02-14
00860007877773LaviorLavior Pharma Inc.NAE2026-02-14
00860010195727LaviorLavior Pharma Inc.NAE2026-02-14
00860010195741LaviorLavior Pharma Inc.NAE2026-02-14
00850072068749CeladiaBiowound Solutions, Inc.NAE2025-12-18
06972864363031sknjxNingbo Chinmed Technology Co., Ltd.NAE2025-12-16
50192253040157KendallCardinal Health 200, LLCNAE2025-09-26
00197998326905Solventum™ Nu-Gel™Solventum US LLCNAE2025-09-22
00197998326981Solventum™ Nu-Gel™Solventum US LLCNAE2025-09-22
00858071004348Advanced Shield Hydrogel Silver Wound Barrier GEL, 2oz TubeKericure Inc.NAE2025-08-26
07290101428350Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDNAE2025-08-25
72901014283670Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDNAE2025-08-25
15056860000072Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
15056860000089Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
00858071004317Advanced Shield Chronic Wound Care, 2ozKericure Inc.NAE2025-08-08
00860000495097Altrazeal Transforming Powder DressingAltrazeal Life Sciences Inc.NAE2025-08-07