GUDIDData
eudamed_udi Primary ID: 00849405000495

UNO+ Negative Pressure Wound Therapy Device (UDI 00849405000495)

Manufactured by Genadyne Biotechnologies, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for UNO+ Negative Pressure Wound Therapy Device - Primary ID 00849405000495

Device Regulatory Overview

The UNO+ Negative Pressure Wound Therapy Device (Model/Catalog Number: UP-S01) is a medical device manufactured by Genadyne Biotechnologies, Inc.. This product is indexed under FDA Product Code / Category Classification Z12019003 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
UP-S01
Product Code / EMDN
Z12019003
Device Name
UNO+ NPWT Device
Database Sync Date
2026-08-09 16:46:28

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of UNO+ Negative Pressure Wound Therapy Device?

The registered manufacturer of record for UNO+ Negative Pressure Wound Therapy Device is Genadyne Biotechnologies, Inc..

What is the Primary UDI-DI identifier for UNO+ Negative Pressure Wound Therapy Device?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00849405000495.

What classification code is assigned to this device?

This device is registered under product classification code Z12019003.

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