XLR8 Abdominal Wound Dressing Kit

GUDID 00849405024101

XLR8 Abdominal wound dressing kit is indicated for use in conjuction with Genadyne NPWT System for patients who have open abdominal wounds with exposed viscera and organs, including but not limited to patients with abdominal compartment syndrome.

GENADYNE BIOTECHNOLOGIES INC.

Negative-pressure wound therapy open-abdomen dressing

• Primary Device ID: 00849405024101
• NIH Device Record Key: c5d2400b-8434-4cca-b46c-212c062cc3e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XLR8 Abdominal Wound Dressing Kit
• Version Model Number: A4-ABDO1-K
• Company DUNS: 006616130
• Company Name: GENADYNE BIOTECHNOLOGIES INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849405024101 [Primary]

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-17
• Device Publish Date: 2026-03-09

Devices Manufactured by GENADYNE BIOTECHNOLOGIES INC.

• 10849405002793 - Hybrid Dressing - Revo Unsterile: 2026-03-24
• 10849405002809 - Hybrid Dressing - Revo Unsterile: 2026-03-24
• 10849405002816 - Hybrid Dressing - Revo Unsterile: 2026-03-24
• 10849405002823 - Hybrid Dressing - Revo Unsterile: 2026-03-24
• 10849405002830 - Hybrid Dressing - Revo Unsterile: 2026-03-24
• 10849405002847 - Hybrid Dressing - Revo Unsterile: 2026-03-24
• 00849405002581 - Genadyne DUO NPWT: 2026-03-17 The Genadyne DUO is a type of negative pressure wound therapy where its intended use is for patients who would benefit from a su
• 00849405024101 - XLR8 Abdominal Wound Dressing Kit: 2026-03-17XLR8 Abdominal wound dressing kit is indicated for use in conjuction with Genadyne NPWT System for patients who have open abdominal wounds with exposed viscera and organs, including but not limited to patients with abdominal compartment syndrome.
• 00849405024101 - XLR8 Abdominal Wound Dressing Kit: 2026-03-17 XLR8 Abdominal wound dressing kit is indicated for use in conjuction with Genadyne NPWT System for patients who have open abdomi