Resp-O2 Disposable Guedel Airway, 40 mm, Newborn, Pink

GUDID 00840117340343

Dynarex Corporation

Oropharyngeal airway, single-use

• Primary Device ID: 00840117340343
• NIH Device Record Key: 7918b91d-3445-4ac6-b1a7-a4894b834a74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2 Disposable Guedel Airway, 40 mm, Newborn, Pink
• Version Model Number: 36315
• Company DUNS: 008124539
• Company Name: Dynarex Corporation
• Device Count: 1
• DM Exempt: false
• 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: false
• 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	00840117340343 [Primary]
GS1	00840117340503 [Package]; Package: Box [10 Units]; In Commercial Distribution
GS1	00840117340596 [Package]; Contains: 00840117340503; Package: Shipper [50 Units]; In Commercial Distribution

FDA Product Code

• CAE: Airway, Oropharyngeal, Anesthesiology

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: 2024-12-09
• Device Publish Date: 2024-11-29

Devices Manufactured by Dynarex Corporation

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• 00840117326620 - Resp-O2 Homecare 800 cc Suction Disposable Canister Full Kit: 2024-12-23 Includes: 800 cc Canister with Float Lid, 1/3" x 6' Suction Tubing, Ridged Elbow Connector, Soft Elbow Connector, Hydrophobic Sh
• 00840117339057 - Durma+ Transparent Film Dressing, Frame Style, Sterile: 2024-12-23 Sterile-EO, Size: 2.36" x 2.75" (6 cm x 7 cm)
• 00840117339088 - Durma+ Transparent Film Dressing, Frame Style, 4" x 4.75" (10 cm x 12 cm ): 2024-12-23 Sterile-EO
• 00840117340213 - Overbed Table H Base, Silver Vein, Walnut: 2024-12-23
• 00840117340220 - Overbed Table, H Base, Silver Vein, Mahogany: 2024-12-23