Well Lead Endotracheal Tube

GUDID 16944932779089

Endotracheal Tubes with Cuff (Oral)8.5

Well Lead Medical Co.,Ltd

Basic endotracheal tube, single-use

• Primary Device ID: 16944932779089
• NIH Device Record Key: 8217aaac-1312-4e02-bf09-468faa716b51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Well Lead Endotracheal Tube
• Version Model Number: A01B01851F
• 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: true
• 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	06944932779082 [Primary]
GS1	16944932779089 [Package]; Contains: 06944932779082; Package: Box [10 Units]; In Commercial Distribution
GS1	26944932779086 [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: 2024-04-04
• Device Publish Date: 2024-03-27

On-Brand Devices [Well Lead Endotracheal Tube]

• 16944932765372: Endotracheal Tubes without Cuff (Oral/Nasal)4.0
• 16944932765365: Endotracheal Tubes without Cuff (Oral/Nasal)3.5
• 16944932765358: Endotracheal Tubes without Cuff (Oral/Nasal)3.0
• 16944932765341: Endotracheal Tubes without Cuff (Oral/Nasal)2.5
• 16944932765334: Endotracheal Tubes without Cuff (Oral/Nasal)2.0
• 16944932738598: Endotracheal Tubes with Cuff (Oral/Nasal)10.0
• 16944932738581: Endotracheal Tubes with Cuff (Oral/Nasal)9.5
• 16944932738574: Endotracheal Tubes with Cuff (Oral/Nasal)9.0
• 16944932738567: Endotracheal Tubes with Cuff (Oral/Nasal)8.5
• 16944932738550: Endotracheal Tubes with Cuff (Oral/Nasal)8.0
• 16944932738543: Endotracheal Tubes with Cuff (Oral/Nasal)7.5
• 16944932738536: Endotracheal Tubes with Cuff (Oral/Nasal)7.0
• 16944932738529: Endotracheal Tubes with Cuff (Oral/Nasal)6.5
• 16944932738512: Endotracheal Tubes with Cuff (Oral/Nasal)6.0
• 16944932738505: Endotracheal Tubes with Cuff (Oral/Nasal)5.5
• 16944932738499: Endotracheal Tubes with Cuff (Oral/Nasal)5.0
• 16944932780757: Endotracheal Tubes without Cuff (Nasal)10.0
• 16944932780733: Endotracheal Tubes without Cuff (Nasal)9.5
• 16944932780719: Endotracheal Tubes without Cuff (Nasal)9.0
• 16944932780696: Endotracheal Tubes without Cuff (Nasal)8.5
• 16944932780672: Endotracheal Tubes without Cuff (Nasal)8.0
• 16944932780658: Endotracheal Tubes without Cuff (Nasal)7.5
• 16944932780634: Endotracheal Tubes without Cuff (Nasal)7.0
• 16944932780610: Endotracheal Tubes without Cuff (Nasal)6.5
• 16944932780597: Endotracheal Tubes without Cuff (Nasal)6.0
• 16944932780573: Endotracheal Tubes without Cuff (Nasal)5.5
• 16944932780559: Endotracheal Tubes without Cuff (Nasal)5.0
• 16944932780535: Endotracheal Tubes without Cuff (Nasal)4.5
• 16944932780511: Endotracheal Tubes without Cuff (Nasal)4.0
• 16944932780504: Endotracheal Tubes without Cuff (Nasal)3.5
• 16944932780498: Endotracheal Tubes without Cuff (Nasal)3.0
• 16944932780474: Endotracheal Tubes with Cuff (Nasal)10.0
• 16944932780443: Endotracheal Tubes with Cuff (Nasal)9.5
• 16944932780405: Endotracheal Tubes with Cuff (Nasal)9.0
• 16944932780368: Endotracheal Tubes with Cuff (Nasal)8.5
• 16944932780320: Endotracheal Tubes with Cuff (Nasal)8.0
• 16944932780283: Endotracheal Tubes with Cuff (Nasal)7.5
• 16944932780245: Endotracheal Tubes with Cuff (Nasal)7.0
• 16944932780207: Endotracheal Tubes with Cuff (Nasal)6.5
• 16944932780160: Endotracheal Tubes with Cuff (Nasal)6.0
• 16944932780122: Endotracheal Tubes with Cuff (Nasal)5.5
• 16944932780085: Endotracheal Tubes with Cuff (Nasal)5.0
• 16944932779447: Endotracheal Tubes without Cuff (Oral)10.0
• 16944932779423: Endotracheal Tubes without Cuff (Oral)9.5
• 16944932779409: Endotracheal Tubes without Cuff (Oral)9.0
• 16944932779386: Endotracheal Tubes without Cuff (Oral)8.5
• 16944932779362: Endotracheal Tubes without Cuff (Oral)8.0
• 16944932779348: Endotracheal Tubes without Cuff (Oral)7.5
• 16944932779324: Endotracheal Tubes without Cuff (Oral)7.0
• 16944932779317: Endotracheal Tubes without Cuff (Oral)6.5