BROOKS DISTEN-U-FLO

GUDID 00821925041844

BROOKS DISTEN-U-FLO TUBING SET (12/PK)

Gyrus ACMI, LLC

Suction/irrigation tubing, single-use

• Primary Device ID: 00821925041844
• NIH Device Record Key: 76a8473f-fe89-4f4c-a0c6-99b07b74ab77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BROOKS DISTEN-U-FLO
• Version Model Number: GY5-TUB
• Company DUNS: 007198742
• Company Name: Gyrus ACMI, LLC
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925002456 [Package]; Package: [12 Units]; In Commercial Distribution
GS1	00821925041844 [Primary]

FDA Product Code

• GAZ: Tubing, Noninvasive

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: 2024-12-02
• Device Publish Date: 2024-11-22

Devices Manufactured by Gyrus ACMI, LLC

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• 00810008185018 - Olympus: 2025-09-29 ES-IP 4K-SDI CXN
• 00810008185032 - Olympus: 2025-09-29 ES-IP NEC M651 65" DISPLAY WALL
• 00810008185063 - Olympus: 2025-09-29 ES-IP DVI/HDMI OUTPUT
• 00821925047150 - Olympus: 2025-09-29 ES-IP DUAL IN-ROOM System - EXPANDED 48U
• 00821925047242 - Olympus: 2025-09-29 ES-IP iOR BWK Hamburg ER (with rack)
• 00821925047259 - Olympus: 2025-09-29 ES-IP iOR BWK Hamburg ER (no rack)
• 00821925047266 - Olympus: 2025-09-29 ES-IP iOR BWK Hamburg OP (with rack)