AG Spiro Foam Kit XF-SPMK1-AG

GUDID 00849405000501

XLR8 PU Foam with AG Kit, Spiro

GENADYNE BIOTECHNOLOGIES INC.

Negative-pressure wound therapy system foam dressing, antimicrobial

• Primary Device ID: 00849405000501
• NIH Device Record Key: c7ec84a6-5564-439a-b68d-bb487cd78582
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AG Spiro Foam Kit
• Version Model Number: XF-SPMK1-AG
• Catalog Number: XF-SPMK1-AG
• 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: 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	00849405000501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082676

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: 2025-01-29
• Device Publish Date: 2025-01-21

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: 2025-01-29XLR8 PU Foam with AG Kit, Spiro
• 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