FDA.reportPublic FDA data

Zeni Medical

Primary DI
00324357020444
Brand
Zeni Medical
Company
Focus Health Group, Inc.
Model
20044-AG
Published
2023-05-31
Public version status
Update
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
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160022000LUOFUCON Silicone Ag foam dressingHuizhou Foryou Medical Devices Co., Ltd.2016-08-17FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30324357020445PackageGS110In Commercial Distribution
50324357020449PackageGS120In Commercial Distribution
00324357020444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3032435702044530324357020445
5032435702044950324357020449
00324357020444003243570204443243570204440324357020444

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, antimicrobialA wound covering typically in the form of a multi-layered pad having a material on its skin-contact surface that prevents adherence to the wound bed (e.g., soft silicone), thereby decreasing the potential for wound trauma, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites. This is a single-use device.

Regulatory Flags#

DUNS number
826939949
Device count
1
DM exempt
false
Premarket exempt
false
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
false
Sterilization required before use
false

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
00324357404145Zeni Medical4004142026-04-13
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
00050428280669CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-06-04
00050428453599CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-06-04
50192253067901ASOCardinal Health 200, LLCFRO2026-06-03
00714196111050DermaRite Medical DermaHoney Medical Grade Honey 0.5 oz TubeSion Brands LLCFRO2026-06-01
00714196111074DermaRite Medical DermaHoney Medical Grade Honey 1.75 oz TubeSion Brands LLCFRO2026-06-01
01714196222045DermaRite Medical DermaHoney Tulle Non Border Honey Gauze 4x4Sion Brands LLCFRO2026-06-01
01714196333048DermaRite Medical DermaHoney Border Medical Grade Honey Sheet 4x4Sion Brands LLCFRO2026-06-01
08717249680130DermaRite Medical L-Mesitran 0.5 oz TubeSion Brands LLCFRO2026-06-01
08717249680147DermaRite Medical L-Mesitran 1.75 oz TubeSion Brands LLCFRO2026-06-01
00850087488259CeeportCEEPORT INC.FRO2026-05-29
00850087488266CeeportCEEPORT INC.FRO2026-05-29
10080196415397MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415386MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415393MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677289MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677296MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
00850087488006CeeportCEEPORT INC.FRO2026-05-22
10197344175994MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-20
10840330706688ProCureTwin Med, LLCFRO2026-05-04
00324357020451Zeni MedicalFocus Health Group, Inc.FRO2026-04-13
00324357020680Zeni MedicalFocus Health Group, Inc.FRO2026-04-13
00324357060440Zeni MedicalFocus Health Group, Inc.FRO2026-04-13
09551012610035ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610196ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610363ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610370ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
10192253046403KendallCardinal Health 200, LLCFRO2026-03-25
10192253046519KendallCardinal Health 200, LLCFRO2026-03-25
09120073781536GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781543GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10