Hybrid Dressing

GUDID 00849405001638

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(10 cm x 30 cm) , UP-D1520(15 cm x 20 cm) , UP-D1530(15 cm x 30 cm), XLR8 Port Pad (XP-1012, XP-1013) and 1 piece transparent film 26 cm x 30 cm cut into 5 pieces is a single patient use, disposable, non-invasive kit designed to be used along with recommended Genadyne NPWT pumps. The kit is intended to be used on moderate to low severity wounds.

GENADYNE BIOTECHNOLOGIES INC.

Negative-pressure wound therapy system foam dressing, non-antimicrobial

• Primary Device ID: 00849405001638
• NIH Device Record Key: d016e992-7a49-4e89-b497-f2f53adecba9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hybrid Dressing
• Version Model Number: UP-D1030
• 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	00849405001638 [Primary]

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: 2024-08-08
• Device Publish Date: 2024-07-31

On-Brand Devices [Hybrid Dressing]

• 10849405002182: Hybrid Dressing 10x40 cm. Case of 5. Each Hybrid Dressing Kit consist of foam dressing with a ho
• 00849405002185: The Genadyne Hybrid Dressing kits which has 5 sizes Hybrid Dressing UP-D1040(10 cm x 40 cm), UP
• 00849405001706: Hybrid Dressing 10x30 cm. Case of 5. Each Hybrid Dressing Kit consist of foam dressing with a ho
• 00849405001690: Hybrid Dressing 10x50 cm. Case of 5. Each Hybrid Dressing Kit consist of foam dressing with a ho
• 00849405001683: Hybrid Dressing 15x20 cm. Case of 5. Each Hybrid Dressing Kit consist of foam dressing with a ho
• 00849405001676: Hybrid Dressing 15x30 cm. Case of 5. Each Hybrid Dressing Kit consist of foam dressing with a ho
• 00849405001669: The Genadyne Hybrid Dressing kits which has 5 sizes Hybrid Dressing UP-D1040(10 cm x 40 cm), UP
• 00849405001652: The Genadyne Hybrid Dressing kits which has 5 sizes Hybrid Dressing UP-D1040(10 cm x 40 cm), UP
• 00849405001645: The Genadyne Hybrid Dressing kits which has 5 sizes Hybrid Dressing UP-D1040(10 cm x 40 cm), UP
• 00849405001638: The Genadyne Hybrid Dressing kits which has 5 sizes Hybrid Dressing UP-D1040(10 cm x 40 cm), UP