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.

• 00849405000013 - XLR8 Transparent Film Dressing: 2023-12-27 Polyurethane film with medical grade acrylic adhesive, size 26 x 30 cm.
• 00849405001454 - XLR8/XLR8+ Port: 2023-12-27 Medical grade suction port that has a PU film with acrylic adhesive attached to it.
• 00849405000389 - UNO Plus 200 CC Collection Canister: 2023-06-21 All canisters are made out of ABS material. It is use as a disposable item to collect patient’s exudates. It comes in 2 sizes:
• 00849405000488 - UNO Plus 300 CC Collection Canister: 2023-06-21 All canisters are made out of ABS material. It is use as a disposable item to collect patient’s exudates. It comes in 2 sizes:
• 00849405000495 - UNO Plus Negative Pressure Wound Therapy Device: 2023-06-21 The Genadyne UNO+ NPWT (Ref # UP-S01) is a multi-patient use, rechargeable Negative Pressure Wound Therapy unit, designed for mo
• 00849405000525 - UNO 10x10 Dressing kit: 2023-06-19 The UNO Dressing is constructed with 4 different layers. The top layer is a polyurethane material, where the suction port is att
• 00849405000532 - UNO 15 Therapy Kit 10x10: 2023-06-19 The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The
• 00849405000549 - UNO 7 Therapy Kit 10x10: 2023-06-19 The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The