XLR8 Transparent Film Dressing A4-S00F5

GUDID 00849405000013

Polyurethane film with medical grade acrylic adhesive, size 26 x 30 cm.

GENADYNE BIOTECHNOLOGIES INC.

Negative-pressure wound therapy system drape

• Primary Device ID: 00849405000013
• NIH Device Record Key: 3805b7f4-0edf-4358-8d09-74d151ac207d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XLR8 Transparent Film Dressing
• Version Model Number: A4-S00F5
• Catalog Number: A4-S00F5
• 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	00849405000013 [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

[00849405000013]

Ethylene Oxide

[00849405000013]

Ethylene Oxide

[00849405000013]

Ethylene Oxide

[00849405000013]

Ethylene Oxide

[00849405000013]

Ethylene Oxide

[00849405000013]

Ethylene Oxide

[00849405000013]

Ethylene Oxide

[00849405000013]

Ethylene Oxide

[00849405000013]

Ethylene Oxide

[00849405000013]

Ethylene Oxide

[00849405000013]

Ethylene Oxide

[00849405000013]

Ethylene Oxide

[00849405000013]

Ethylene Oxide

[00849405000013]

Ethylene Oxide

[00849405000013]

Ethylene Oxide

[00849405000013]

Ethylene Oxide

[00849405000013]

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.

• 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
• 00849405000426 - 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.
• 00849405001638 - Hybrid Dressing: 2024-08-08 The Genadyne Hybrid Dressing kits which has 5 sizes Hybrid Dressing UP-D1040(10 cm x 40 cm), UP-D1050(10 cm x 50 cm), UP-D1030(
• 00849405001645 - Hybrid Dressing: 2024-08-08 The Genadyne Hybrid Dressing kits which has 5 sizes Hybrid Dressing UP-D1040(10 cm x 40 cm), UP-D1050(10 cm x 50 cm), UP-D1030(
• 00849405001652 - Hybrid Dressing: 2024-08-08 The Genadyne Hybrid Dressing kits which has 5 sizes Hybrid Dressing UP-D1040(10 cm x 40 cm), UP-D1050(10 cm x 50 cm), UP-D1030(