FDA.reportPublic FDA data

Zeni Medical

Primary DI
00324357404145
Brand
Zeni Medical
Company
Focus Health Group, Inc.
Model
400414
Published
2026-04-13
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

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
00324357404145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00324357404145003243574041453243574041450324357404145

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
826939949
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00324357010155Zeni Medical10015-AG2026-04-13
00324357020451Zeni Medical20045-AG2026-04-13
00324357020680Zeni Medical20068-AG2026-04-13
00324357060440Zeni Medical60044-AG2026-04-13
00324357100252Zeni Medical10025252026-04-13
00324357104045Zeni Medical1000442026-04-13
00324357200457Zeni Medical200452026-04-13
00324357200488Zeni Medical200482026-04-13
00324357200884Zeni Medical200882026-04-13
00324357400482Zeni Medical200482026-04-13
00324357410016Zeni Medical410232026-04-13
00324357410023Zeni Medical4103542026-04-13
00324357410030Zeni Medical410462026-04-13
00324357410047Zeni Medical410482026-04-13
00324357410054Zeni Medical4104102026-04-13
00324357410061Zeni Medical4104142026-04-13
00324357410078Zeni Medical30001H2026-04-13
00324357410085Zeni Medical801442026-04-13
00324357410092Zeni Medical801552026-04-13
00324357410108Zeni Medical810662026-04-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840330701560ProCureTwin Med, LLCNAD2026-04-28
10840330701577ProCureTwin Med, LLCNAD2026-04-28
10840330701584ProCureTwin Med, LLCNAD2026-04-28
10840330701591ProCureTwin Med, LLCNAD2026-04-28
10840330701607ProCureTwin Med, LLCNAD2026-04-28
10840330701614ProCureTwin Med, LLCNAD2026-04-28
10840330701621ProCureTwin Med, LLCNAD2026-04-28
10840330701638ProCureTwin Med, LLCNAD2026-04-28
10840330701645ProCureTwin Med, LLCNAD2026-04-28
10840330701652ProCureTwin Med, LLCNAD2026-04-28
10840330701669ProCureTwin Med, LLCNAD2026-04-28
10840330704899ProCureTwin Med, LLCNAD2026-04-22
10840330705032ProCureTwin Med, LLCNAD2026-04-22
10193489093902MEDLINEMEDLINE INDUSTRIES, INC.NAD2026-01-29
10735471024695PolyMemFERRIS MFG. CORP.NAD2026-01-14
10197344169566MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-12-12
10192253038811KendallCardinal Health 200, LLCNAD2025-11-21
10192253038828KendallCardinal Health 200, LLCNAD2025-11-21
10192253038866KendallCardinal Health 200, LLCNAD2025-11-21
10197344169559MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-14
10197344162512MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-07
10197344169344MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-07
10197344169351MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-07
10197344169368MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-07
10197344169375MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-07
10197344162505MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-10-17
10197344162529MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-10-17
10197344162536MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-10-17
10197344162543MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-10-17
10080196735662MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-10-15