FDA.reportPublic FDA data

UNO 10x20 Dressing Kit

Primary DI
00849405021513
Brand
UNO 10x20 Dressing Kit
Company
GENADYNE BIOTECHNOLOGIES INC.
Model
UNO-0408
Device description
The UNO Dressing is constructed with 4 different layers. The top layer is a polyurethane material, where the suction port is attached to. The 2nd layer is a super absorbent layer, 3rd layer is a foam layer, and the bottom layer that is skin/ wound contacting is a silicone gel adhesive layer.
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849405021513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849405021513008494050215138494050215130849405021513

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system, electric, single-useA portable assembly of devices designed to apply suction to help heal traumatic and chronic skin wounds (e.g., grafts, incisions, burns, ulcers) with low to moderate levels of exudate. It typically consists of an electrically-powered vacuum pump, a highly-absorbent wound dressing and/or collection canister to contain the exudate, and a connection tube. The pump applies continuous or intermittent negative pressure to the wound via the tube/dressing to decompress capillaries/lymphatic vessels, improve blood/interstitial fluid circulation, draw wound edges together, facilitate granulation tissue formation, and prepare the wound bed for closure. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
006616130
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true
Sterilization required before use
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
00849405002581Genadyne DUO NPWTA7-S00012026-03-09
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

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Primary DI, Brand, Company table
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00849405002819Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
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