Resp-O2 Endotracheal Tube Cuffed, 8.5 mm

GUDID 00840117313088

Sterile-Eo

Dynarex Corporation

Basic endotracheal tube, single-use

• Primary Device ID: 00840117313088
• NIH Device Record Key: d95af905-b9bc-4bc5-a1f2-104f601a6139
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2 Endotracheal Tube Cuffed, 8.5 mm
• Version Model Number: 36243
• Company DUNS: 008124539
• Company Name: Dynarex Corporation
• 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: true
• Expiration Date: false
• 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	00840117313088 [Package]; Contains: 00840117317543; Package: Box [10 Units]; In Commercial Distribution
GS1	00840117313095 [Package]; Package: Shipper [10 Units]; In Commercial Distribution
GS1	00840117317543 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042683

FDA Product Code

• BTR: Tube, Tracheal (W/Wo Connector)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-01
• Device Publish Date: 2024-10-24

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