AlphaCleanse® Antimicrobial Wound Care System 5750

GUDID 00714646000804

AlphaCleanse® Antimicrobial Wound Care System

Bionix, LLC

Wound irrigation kit

• Primary Device ID: 00714646000804
• NIH Device Record Key: b12e2884-eb0b-47f2-8d7c-28e19af1808b
• Commercial Distribution Discontinuation: 2024-01-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AlphaCleanse® Antimicrobial Wound Care System
• Version Model Number: WI-5750
• Catalog Number: 5750
• Company DUNS: 117844489
• Company Name: Bionix, LLC
• Device Count: 1
• DM Exempt: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)551-7096
• Email: Bionix@Bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@Bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@Bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@Bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@Bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@Bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@Bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@Bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@Bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@Bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@Bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@Bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@Bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@Bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@Bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@Bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@Bionix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00714646000804 [Primary]

FDA Product Code

• FQH: LAVAGE, JET

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00714646000804]

Radiation Sterilization

[00714646000804]

Radiation Sterilization

[00714646000804]

Radiation Sterilization

[00714646000804]

Radiation Sterilization

[00714646000804]

Radiation Sterilization

[00714646000804]

Radiation Sterilization

[00714646000804]

Radiation Sterilization

[00714646000804]

Radiation Sterilization

[00714646000804]

Radiation Sterilization

[00714646000804]

Radiation Sterilization

[00714646000804]

Radiation Sterilization

[00714646000804]

Radiation Sterilization

[00714646000804]

Radiation Sterilization

[00714646000804]

Radiation Sterilization

[00714646000804]

Radiation Sterilization

[00714646000804]

Radiation Sterilization

[00714646000804]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-01-08
• Device Publish Date: 2021-11-18

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• 10714646001129 - Sample: Opti-Tatt: 2025-06-30 Opti-Tatt Sample - 2 Dot, 2 Crosshair, 2 Field Border
• 00714646001382 - Prone Breast, Cushion, Contralateral Breast Insert, 15 degree, Replacement: 2025-06-05 Prone Breast, Cushion, Contralateral Breast Insert, 15 degree, Replacement
• 00714646001399 - Prone Breast, Face Cushion, Replacement: 2025-06-05 Prone Breast, Face Cushion, Replacement
• 00714646001405 - Prone Breast, Arm Rest, Replacement: 2025-06-05 Prone Breast, Arm Rest, Replacement
• 00714646001412 - Prone Breast, Leg Cushion, Replacement: 2025-06-05 Prone Breast, Leg Cushion, Replacement
• 00714646001429 - Prone Breast, Hand Post Assembly, Replacement: 2025-06-05 Prone Breast, Hand Post Assembly, Replacement