UNO 15 Therapy Kit 10x40

Primary DI
00849405011538
Brand
UNO 15 Therapy Kit 10x40
Company
GENADYNE BIOTECHNOLOGIES INC.
Model
U-S1040-5
Device description
The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
00849405011538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849405011538008494050115388494050115380849405011538

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

Regulatory Flags#

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

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Primary DI, Brand, Model table
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