Genadyne XLR8+ Wound Vacuum System

GUDID 00849405011309

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.

GENADYNE BIOTECHNOLOGIES INC.

Negative-pressure wound therapy system pump, electric

• Primary Device ID: 00849405011309
• NIH Device Record Key: 03427544-0cc5-43dc-86c7-dbd5693ccdd0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genadyne XLR8+ Wound Vacuum System
• Version Model Number: A4-S0003
• Company DUNS: 006616130
• Company Name: GENADYNE BIOTECHNOLOGIES INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00849405011309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143726

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by GENADYNE BIOTECHNOLOGIES INC.

• 00849405002598 - Hybrid Dressing: 2025-12-11 The Genadyne Hybrid Dressing kits which has a silicone adhesive dressing with green PU foam encapsulated in the middle, XLR8 Por
• 00849405002659 - XLR8/XLR8+ Port - Unsterile: 2025-12-11 Unsterile Medical grade suction port that has a PU film with acrylic adhesive attached to it.
• 00849405002666 - XLR8 Transparent Film Dressing: 2025-12-11 Unsterile Polyurethane film with medical grade acrylic adhesive, size 26 x 30 cm.
• 10849405002595 - Hybrid Dressing: 2025-12-11 Hybrid Dressing 10x20 cm. Case of 5. Each Hybrid Dressing Kit consist of foam dressing with a hole, port film dressing and drape
• 00849405000501 - AG Spiro Foam Kit: 2025-01-29 XLR8 PU Foam with AG Kit, Spiro
• 00849405022114 - AG Foam Kit Small: 2025-01-29 XLR8 PU Foam with AG Kit, Small
• 00849405022121 - AG Foam Kit Medium: 2025-01-29 XLR8 PU Foam with AG Kit, Medium
• 00849405022138 - AG Foam Kit Large: 2025-01-29 XLR8 PU Foam with AG Kit, Large