AccessGUDID - DEVICE: UNO Plus Negative Pressure Wound Therapy Device (00849405000495)

GUDID

Device Identifier (DI) Information

Brand Name: UNO Plus Negative Pressure Wound Therapy Device
Version or Model: UP-S01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GENADYNE BIOTECHNOLOGIES INC.

Primary DI Number: 00849405000495
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006616130 *Terms of Use

Device Description: The Genadyne UNO+ NPWT (Ref # UP-S01) is a multi-patient use, rechargeable Negative Pressure Wound Therapy unit, designed for moderate to low severity wounds. The UNO+ NPWT features an interface panel which provides 5 alerts to the user, selectable therapy modes (continuous mode and variable mode) and multi pressure options (40mmHg, 60mmHg,80mmHg, 100mmHg or 125mmHg). The UNO+ NPWT is packaged in a box that includes a universal charger, USB cable, a user manual and a user carry bag. It will be made compatible with the dressing kits that was already approved under K143726. The dressing kits includes the transparent film dressings, a choice of wound filler (i.e. XLR8 green foam, Genadyne Hybrid Dressing) and the XLR8 Port Pad. The UNO+ NPWT is designed to be used with a canister collection system. The canister will have 2 sizes available (200cc and 300cc). Therapy duration of the dressing may be less than indicated if clinical practice or other factors such as wound type, wound size, rate or volume of exudate, orientation of the dressing or environmental conditions, result in more frequent dressing changes.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47408	Negative-pressure wound therapy system pump, electric	A mains electricity (AC-powered) device intended to create and control negative pressure in a vacuum-assisted wound closure system during negative pressure wound therapy (NPWT) for the treatment of hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. It is typically a computer-controlled vacuum pump with controls and display for continuous or intermittent negative pressure delivered through a tubing set to the open-cell foam dressing located at the airtight-sealed wound. It typically has internal batteries that allow the device to operate for a short period without line power (e.g., during transport or a power outage).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OMP	Negative Pressure Wound Therapy Powered Suction Pump

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210107	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 37c2f892-e1f3-4a07-9830-e0f2f2065d94
Public Version Date: June 21, 2023
Public Version Number: 1
DI Record Publish Date: June 13, 2023