FDA.reportPublic FDA data

Genadyne DUO NPWT

Primary DI
00849405002581
Brand
Genadyne DUO NPWT
Company
GENADYNE BIOTECHNOLOGIES INC.
Model
A7-S0001
Device description
The Genadyne DUO is a type of negative pressure wound therapy where its intended use is for patients who would benefit from a suction device particularly as the device may promote wound healing.
Published
2026-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
OMPNegative Pressure Wound Therapy Powered Suction Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233614000Genadyne DUO NPWTGenadyne Biotechnologies, Inc.2024-12-23OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849405002581PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849405002581008494050025818494050025810849405002581

GMDN Terms#

Term, Definition table
TermDefinition
Irrigation negative-pressure wound therapy unitA mains electricity (AC-powered) device designed to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic) using suction combined with instillation/aspiration of wound treatment solutions (e.g., saline) over the wound bed. It typically includes controls and a user-interface to vary negative pressure and irrigation parameters, tubing, and a collection receptacle. It is intended to reduce oedema, promote granulation tissue formation, and remove exudates and infectious material.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006616130
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849405002796Hybrid Dressing - Revo UnsterileHFD-D1040-UNS2026-03-16
00849405002802Hybrid Dressing - Revo UnsterileHFD-D1050-UNS2026-03-16
00849405002819Hybrid Dressing - Revo UnsterileHFD-D1030-UNS2026-03-16
00849405002826Hybrid Dressing - Revo UnsterileHFD-D1530-UNS2026-03-16
00849405002833Hybrid Dressing - Revo UnsterileHFD-D1520-UNS2026-03-16
00849405002840Hybrid Dressing - Revo UnsterileHFD-D1020-UNS2026-03-16
10849405002793Hybrid Dressing - Revo UnsterileHFD-D1040-UNS2026-03-16
10849405002809Hybrid Dressing - Revo UnsterileHFD-D1050-UNS2026-03-16
10849405002816Hybrid Dressing - Revo UnsterileHFD-D1030-UNS2026-03-16
10849405002823Hybrid Dressing - Revo UnsterileHFD-D1530-UNS2026-03-16
10849405002830Hybrid Dressing - Revo UnsterileHFD-D1520-UNS2026-03-16
10849405002847Hybrid Dressing - Revo UnsterileHFD-D1020-UNS2026-03-16
00849405024101XLR8 Abdominal Wound Dressing Kit A4-ABDO1-K2026-03-09
00849405002659XLR8/XLR8+ Port - UnsterileXP-1013-UNSXP-1013-UNS2025-12-03
00849405002666XLR8 Transparent Film DressingA4-S00F5-UNSA4-S00F5-UNS2025-12-03
00849405002673Hybrid Dressing - RevoHFD-D1020HFD-D10202026-01-12
00849405002680Hybrid Dressing - RevoHFD-D1520HFD-D15202026-01-12
00849405002697Hybrid Dressing - RevoHFD-D1030HFD-D10302026-01-12
00849405002703Hybrid Dressing - RevoHFD-D1530HFD-D15302026-01-12
00849405002710Hybrid Dressing - RevoHFD-D1040HFD-D10402026-01-12

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Primary DI, Brand, Company table
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00849405002802Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002819Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002826Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002833Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002840Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
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00849405002703Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002710Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
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10851978007662WoundPro+ Collection CanisterPensar Medical, LLCOMP2025-03-18
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