Igloo Wound Irrigator 25000

GUDID 00714646000606

Wound Irrigation - Sample

Bionix, LLC

Wound irrigation kit

• Primary Device ID: 00714646000606
• NIH Device Record Key: 5a554fda-16a3-4e69-b225-bbbb562ff82a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Igloo Wound Irrigator
• Version Model Number: 25000
• Catalog Number: 25000
• Company DUNS: 117844489
• Company Name: Bionix, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00714646000606 [Primary]

FDA Product Code

• KYZ: SYRINGE, IRRIGATING (NON DENTAL)

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: 2024-10-03
• Device Publish Date: 2024-09-25

Devices Manufactured by Bionix, LLC

• 00714646001283 - Suture Removal Kit: 2025-03-20 Suture Removal Kit - 50ct case
• 10714646001303 - ClearLook Lighted AngleLoop, Refill: 2025-03-05 ClearLook Lighted AngleLoop, 50ct Refill
• 10714646001310 - ClearLook Lighted MicroLoop, Refill: 2025-03-05 ClearLook Lighted MicroLoop, 50ct Refill
• 10714646001327 - ClearLook Lighted VersaLoop, Refill: 2025-03-05 ClearLook Lighted VersaLoop, 50ct Refill
• 10714646001334 - ClearLook Lighted FlexLoop, Refill: 2025-03-05 ClearLook Lighted FlexLoop, 50ct Refill
• 10714646001341 - ClearLook Lighted Variety Pack, Refill: 2025-03-05 ClearLook Lighted Variety Pack, 50ct Refill
• 10714646001358 - ClearLook Lighted InfantScoop, Refill: 2025-03-05 ClearLook Lighted InfantScoop, 50ct Refill
• 10714646001365 - ClearLook Lighted Variety Pack with Rechargeable Light Source: 2025-03-05 ClearLook Lighted Variety Pack with Rechargeable Light Source