XLR8/XLR8+ Port - Unsterile XP-1013-UNS

GUDID 00849405002659

Unsterile 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: 00849405002659
• NIH Device Record Key: aac108f6-591c-41e7-b311-5d8f65edaa0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XLR8/XLR8+ Port - Unsterile
• Version Model Number: XP-1013-UNS
• Catalog Number: XP-1013-UNS
• 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	00849405002659 [Primary]
GS1	10849405002656 [Package]; Package: [10 Units]; In Commercial Distribution

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

[00849405002659]

Ethylene Oxide

[00849405002659]

Ethylene Oxide

[00849405002659]

Ethylene Oxide

[00849405002659]

Ethylene Oxide

[00849405002659]

Ethylene Oxide

[00849405002659]

Ethylene Oxide

[00849405002659]

Ethylene Oxide

[00849405002659]

Ethylene Oxide

[00849405002659]

Ethylene Oxide

[00849405002659]

Ethylene Oxide

[00849405002659]

Ethylene Oxide

[00849405002659]

Ethylene Oxide

[00849405002659]

Ethylene Oxide

[00849405002659]

Ethylene Oxide

[00849405002659]

Ethylene Oxide

[00849405002659]

Ethylene Oxide

[00849405002659]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-11
• Device Publish Date: 2025-12-03

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: 2026-03-17 XLR8 Abdominal wound dressing kit is indicated for use in conjuction with Genadyne NPWT System for patients who have open abdomi