XLR8/XLR8+ Port XP-1013

GUDID 00849405001454

Medical grade suction port that has a PU film with acrylic adhesive attached to it.

GENADYNE BIOTECHNOLOGIES INC.

Irrigation negative-pressure wound therapy unit

• Primary Device ID: 00849405001454
• NIH Device Record Key: 3060e5bf-2552-46eb-a139-03d27874ffed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XLR8/XLR8+ Port
• Version Model Number: XP-1013
• Catalog Number: XP-1013
• 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: false
• 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	00849405001454 [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: true
• Device Is Sterile: true

[00849405001454]

Ethylene Oxide

[00849405001454]

Ethylene Oxide

[00849405001454]

Ethylene Oxide

[00849405001454]

Ethylene Oxide

[00849405001454]

Ethylene Oxide

[00849405001454]

Ethylene Oxide

[00849405001454]

Ethylene Oxide

[00849405001454]

Ethylene Oxide

[00849405001454]

Ethylene Oxide

[00849405001454]

Ethylene Oxide

[00849405001454]

Ethylene Oxide

[00849405001454]

Ethylene Oxide

[00849405001454]

Ethylene Oxide

[00849405001454]

Ethylene Oxide

[00849405001454]

Ethylene Oxide

[00849405001454]

Ethylene Oxide

[00849405001454]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-27
• Device Publish Date: 2023-12-19

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