PVA Foam Kit Medium

GUDID 00849405025122

The Genadyne PVA Foam Kit Medium consists of a XLR8 Port, XLR8 Transparent Film and a White PVA Foam Medium. Each component are packaged, sealed and sterilized individually and then bagged into a kit.

GENADYNE BIOTECHNOLOGIES INC.

Negative-pressure wound therapy system foam dressing

• Primary Device ID: 00849405025122
• NIH Device Record Key: ec2d8848-8793-4d7e-b09b-2fdeceba1282
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PVA Foam Kit Medium
• Version Model Number: PVA-FOAM1
• 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: true
• 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	00849405025122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142646

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.

• 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
• 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