AIRCARE Endotracheal Tube

GUDID 30351688073130

Endotracheal Tubes with Cuff (Oral/Nasal)4.5

Well Lead Medical Co.,Ltd

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• Primary Device ID: 30351688073130
• NIH Device Record Key: c10e2611-d484-49b1-9a2d-2387043cc137
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIRCARE Endotracheal Tube
• Version Model Number: 100/100/045
• Company DUNS: 544811862
• Company Name: Well Lead Medical Co.,Ltd
• 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	00351688073139 [Primary]
GS1	30351688073130 [Package]; Contains: 00351688073139; Package: Box [10 Units]; In Commercial Distribution
GS1	50351688073134 [Package]; Package: Carton [10 Units]; In Commercial Distribution

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: 2023-11-15
• Device Publish Date: 2023-11-07

On-Brand Devices [AIRCARE Endotracheal Tube ]

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• 30351688073567: Endotracheal Tubes without Cuff, Stylet (Oral/Nasal)4.0
• 30351688073550: Endotracheal Tubes without Cuff, Stylet (Oral/Nasal)3.5
• 30351688073543: Endotracheal Tubes without Cuff, Stylet (Oral/Nasal)3.0
• 30351688073536: Endotracheal Tubes with Cuff, Stylet (Oral/Nasal)10.0
• 30351688073529: Endotracheal Tubes with Cuff, Stylet (Oral/Nasal)9.0
• 30351688073512: Endotracheal Tubes with Cuff, Stylet (Oral/Nasal)8.5
• 30351688073505: Endotracheal Tubes with Cuff, Stylet (Oral/Nasal)8.0
• 30351688073499: Endotracheal Tubes with Cuff, Stylet (Oral/Nasal)7.5
• 30351688073482: Endotracheal Tubes with Cuff, Stylet (Oral/Nasal)7.0
• 30351688073475: Endotracheal Tubes with Cuff, Stylet (Oral/Nasal)6.5
• 30351688073468: Endotracheal Tubes with Cuff, Stylet (Oral/Nasal)6.0
• 30351688073451: Endotracheal Tubes with Cuff, Stylet (Oral/Nasal)5.5
• 30351688073444: Endotracheal Tubes with Cuff, Stylet (Oral/Nasal)5.0
• 30351688073437: Endotracheal Tubes with Cuff, Stylet (Oral/Nasal)4.5
• 30351688073420: Endotracheal Tubes with Cuff, Stylet (Oral/Nasal)4.0
• 30351688073413: Endotracheal Tubes with Cuff, Stylet (Oral/Nasal)3.5
• 30351688073406: Endotracheal Tubes with Cuff Stylet (Oral/Nasal)3.0
• 30351688073390: Endotracheal Tubes without Cuff (Oral/Nasal)10.0
• 30351688073383: Endotracheal Tubes without Cuff (Oral/Nasal)9.0
• 30351688073376: Endotracheal Tubes without Cuff (Oral/Nasal)8.5
• 30351688073369: Endotracheal Tubes without Cuff (Oral/Nasal)8.0
• 30351688073352: Endotracheal Tubes without Cuff (Oral/Nasal)7.5
• 30351688073345: Endotracheal Tubes without Cuff (Oral/Nasal)7.0
• 30351688073338: Endotracheal Tubes without Cuff (Oral/Nasal)6.5
• 30351688073321: Endotracheal Tubes without Cuff (Oral/Nasal)6.0
• 30351688073314: Endotracheal Tubes without Cuff (Oral/Nasal)5.5
• 30351688073307: Endotracheal Tubes without Cuff (Oral/Nasal)5.0
• 30351688073291: Endotracheal Tubes without Cuff (Oral/Nasal)4.5
• 30351688073284: Endotracheal Tubes without Cuff (Oral/Nasal)4.0
• 30351688073277: Endotracheal Tubes without Cuff (Oral/Nasal)3.5
• 30351688073260: Endotracheal Tubes without Cuff (Oral/Nasal)3.0
• 30351688073239: Endotracheal Tubes with Cuff (Oral/Nasal)10.0
• 30351688073222: Endotracheal Tubes with Cuff (Oral/Nasal)9.0
• 30351688073215: Endotracheal Tubes with Cuff (Oral/Nasal)8.5
• 30351688073208: Endotracheal Tubes with Cuff (Oral/Nasal)8.0
• 30351688073192: Endotracheal Tubes with Cuff (Oral/Nasal)7.5
• 30351688073185: Endotracheal Tubes with Cuff (Oral/Nasal)7.0
• 30351688073178: Endotracheal Tubes with Cuff (Oral/Nasal)6.5
• 30351688073161: Endotracheal Tubes with Cuff (Oral/Nasal)6.0
• 30351688073154: Endotracheal Tubes with Cuff (Oral/Nasal)5.5
• 30351688073147: Endotracheal Tubes with Cuff (Oral/Nasal)5.0
• 30351688073130: Endotracheal Tubes with Cuff (Oral/Nasal)4.5
• 30351688073123: Endotracheal Tubes with Cuff (Oral/Nasal)4.0
• 30351688073116: Endotracheal Tubes with Cuff (Oral/Nasal)3.5
• 30351688073109: Endotracheal Tubes with Cuff (Oral/Nasal)3.0