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Genadyne XLR8 Wound Vacuum System

FDA UDI

Class II (US FDA UDI)

by Genadyne Biotechnologies, Inc.

Identity

Trade Name
Genadyne XLR8 Wound Vacuum System FDA UDI
Generic Name
Negative-pressure wound therapy system pump, electric FDA UDI
Device Name
The Genadyne XLR8 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. FDA UDI
Model / Reference
A4-S0002 FDA UDI
Description
The Genadyne XLR8 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. FDA UDI

Identifiers

Primary DI / UDI-DI
00849405011200 FDA UDI
510(k) Number
K090638 FDA UDI
FDA Product Code
OMP FDA UDI
GMDN Term
Negative-pressure wound therapy system pump, electric FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4780 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Negative-pressure wound therapy system pump, electric

Genadyne XLR8 Wound Vacuum System by Genadyne Biotechnologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Negative-pressure wound therapy system pump, electric.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Genadyne Biotechnologies, Inc.

Sources (1)

  • FDA UDI 96d3fd5d-d3a3-4f0e-a0cd-471d480b44c6 34 fields · synced Jun 4, 2026