Well Lead Tracheostomy Tube

GUDID 16936881181112

TRACHEOSTOMY TUBES (Uncuffed)I.D. 2.5

Well Lead Medical Co.,Ltd

Tracheostomy tube, non-reinforced, non-customized, single-use

• Primary Device ID: 16936881181112
• NIH Device Record Key: 479d16cd-625a-4b47-98ff-a997763d75a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Well Lead Tracheostomy Tube
• Version Model Number: A02A042530
• 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	06936881181115 [Primary]
GS1	16936881181112 [Package]; Contains: 06936881181115; Package: Box [10 Units]; In Commercial Distribution
GS1	26936881181119 [Package]; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042684

FDA Product Code

• BTO: Tube, Tracheostomy (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: 2024-03-29
• Device Publish Date: 2024-03-21

On-Brand Devices [Well Lead Tracheostomy Tube]

• 16944932702933: TRACHEOSTOMY TUBES (Uncuffed)I.D. 10.0
• 16944932702926: TRACHEOSTOMY TUBES (Uncuffed)I.D. 9.5
• 16944932702919: TRACHEOSTOMY TUBES (Uncuffed)I.D. 9.0
• 16944932702902: TRACHEOSTOMY TUBES (Uncuffed)I.D. 8.5
• 16944932702896: TRACHEOSTOMY TUBES (Uncuffed)I.D. 8.0
• 16944932702889: TRACHEOSTOMY TUBES (Uncuffed)I.D. 7.5
• 16944932702872: TRACHEOSTOMY TUBES (Uncuffed)I.D. 7.0
• 16944932702865: TRACHEOSTOMY TUBES (Uncuffed)I.D. 6.5
• 16944932702858: TRACHEOSTOMY TUBES (Uncuffed)I.D. 6.0
• 16944932702841: TRACHEOSTOMY TUBES (Uncuffed)I.D. 5.5
• 16944932702834: TRACHEOSTOMY TUBES (Uncuffed)I.D. 5.0
• 16944932702827: TRACHEOSTOMY TUBES (Uncuffed)I.D. 4.5
• 16944932702810: TRACHEOSTOMY TUBES (Uncuffed)I.D. 4.0
• 16944932702803: TRACHEOSTOMY TUBES (Uncuffed)I.D. 3.5
• 16944932702797: TRACHEOSTOMY TUBES (Uncuffed)I.D. 3.0
• 16944932702780: TRACHEOSTOMY TUBES (Cuffed)I.D. 10.0
• 16944932702773: TRACHEOSTOMY TUBES (Cuffed)I.D. 9.5
• 16944932702766: TRACHEOSTOMY TUBES (Cuffed)I.D. 9.0
• 16944932702759: TRACHEOSTOMY TUBES (Cuffed)I.D. 8.5
• 16944932702742: TRACHEOSTOMY TUBES (Cuffed)I.D. 8.0
• 16944932702735: TRACHEOSTOMY TUBES (Cuffed)I.D. 7.5
• 16944932702728: TRACHEOSTOMY TUBES (Cuffed)I.D. 7.0
• 16944932702711: TRACHEOSTOMY TUBES (Cuffed)I.D. 6.5
• 16944932702704: TRACHEOSTOMY TUBES (Cuffed)I.D. 6.0
• 16944932702698: TRACHEOSTOMY TUBES (Cuffed)I.D. 5.5
• 16944932702681: TRACHEOSTOMY TUBES (Cuffed)I.D. 5.0
• 16944932702674: TRACHEOSTOMY TUBES (Cuffed)I.D. 4.5
• 16944932702667: TRACHEOSTOMY TUBES (Cuffed)I.D. 4.0
• 16944932702650: TRACHEOSTOMY TUBES (Cuffed)I.D. 3.5
• 16944932702643: TRACHEOSTOMY TUBES (Cuffed)I.D. 3.0
• 16936881181136: TRACHEOSTOMY TUBES (Uncuffed)I.D. 11.0
• 16936881181129: TRACHEOSTOMY TUBES (Uncuffed)I.D. 10.5
• 16936881181112: TRACHEOSTOMY TUBES (Uncuffed)I.D. 2.5
• 16936881181105: TRACHEOSTOMY TUBES (Uncuffed)I.D. 2.0
• 16936881181099: TRACHEOSTOMY TUBES (Cuffed)I.D. 11.0
• 16936881181082: TRACHEOSTOMY TUBES (Cuffed)I.D. 10.5