Resp-O2 Endotracheal Tube With Stylette, Cuffed 8.0 mm

GUDID 00840117317642

DYNAREX CORPORATION

Basic endotracheal tube, single-use

• Primary Device ID: 00840117317642
• NIH Device Record Key: c6cf9bb2-e6a3-4081-b096-17335b40fc14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2 Endotracheal Tube With Stylette, Cuffed 8.0 mm
• Version Model Number: 36253
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840117313286 [Package]; Package: Box [10 Units]; In Commercial Distribution
GS1	00840117313293 [Package]; Contains: 00840117313286; Package: Case [10 Units]; In Commercial Distribution
GS1	00840117317642 [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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-24
• Device Publish Date: 2022-05-16

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