AG Foam Kit Medium AG-MFOAM2

GUDID 00849405022121

XLR8 PU Foam with AG Kit, Medium

GENADYNE BIOTECHNOLOGIES INC.

Negative-pressure wound therapy system foam dressing, antimicrobial

• Primary Device ID: 00849405022121
• NIH Device Record Key: c41cb5a6-dc1a-4bc0-be62-859992512898
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AG Foam Kit Medium
• Version Model Number: AG-MFOAM2
• Catalog Number: AG-MFOAM2
• 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	00849405022121 [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.

• 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: 2025-01-29XLR8 PU Foam with AG Kit, Medium
• 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
• 00849405000051 - XLR8 Canister: 2024-08-13 All canisters are made out of ABS material. It is used as a disposable item to collect patient’s exudates.
• 00849405000396 - XLR8 Canister: 2024-08-13 All canisters are made out of ABS material. It is used as a disposable item to collect patient’s exudates.
• 00849405000402 - XLR8 Canister: 2024-08-13 All canisters are made out of ABS material. It is used as a disposable item to collect patient’s exudates
• 00849405000419 - XLR8 Canister: 2024-08-13 All canisters are made out of ABS material. It is used as a disposable item to collect patient’s exudates