Gyrus ACMI

GUDID 00821925044630

DURAVENT VENTILATION TUBE WITH TWIN SPOON FLANGES 1.27 MM I.D. BLUE SILICONE TAPERED LUMEN

Gyrus Acmi, Inc.

Tympanostomy tube

• Primary Device ID: 00821925044630
• NIH Device Record Key: 4dc64a2b-ecfc-4da6-89ea-08b9e44f49e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gyrus ACMI
• Version Model Number: 245775
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• Device Count: 2
• 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	00821925018143 [Package]; Contains: 00821925032439; Package: [60 Units]; In Commercial Distribution
GS1	00821925032439 [Primary]
GS1	00821925044630 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932166

FDA Product Code

• ETD: Tube, Tympanostomy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-07-22
• Device Publish Date: 2020-02-11

On-Brand Devices [Gyrus ACMI]

• 00821925038356: Ellik Tubing For Ellik/Toomey Adapters
• 00821925015708: SCHUKNECHT CRESCENT FLUOROPLASTIC
• 00821925044630: DURAVENT VENTILATION TUBE WITH TWIN SPOON FLANGES 1.27 MM I.D. BLUE SILICONE TAPERED LUMEN
• 00821925028913: Single Incision Inner Tube Assembly