NAR

GUDID 06936881136009

Tracheostomy Tube, Type I, Cuffed, 6.0mm DEHP FREE(Sterile)

Well Lead Medical Co.,Ltd

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

• Primary Device ID: 06936881136009
• NIH Device Record Key: ffdb559e-33c1-4d07-b876-34d23a42b0e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NAR
• Version Model Number: ZZ-0269
• 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	06936881136009 [Primary]
GS1	16936881136006 [Package]; Package: box [10 Units]; In Commercial Distribution
GS1	26936881136003 [Package]; Contains: 16936881136006; 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: 2022-04-08
• Device Publish Date: 2022-03-31

Devices Manufactured by Well Lead Medical Co.,Ltd

• 16936881134446 - PVC Urethral Catheter: 2024-05-07 Female, 1-way 12Fr
• 16936881134453 - PVC Urethral Catheter: 2024-05-07 Female, 1-way 14Fr
• 16936881134460 - PVC Urethral Catheter: 2024-05-07 Female, 1-way 16Fr
• 16936881134477 - PVC Urethral Catheter: 2024-05-07 Female, 1-way 18Fr
• 16936881134484 - PVC Urethral Catheter: 2024-05-07 Female, 1-way 20Fr
• 16936881134491 - PVC Urethral Catheter: 2024-05-07 Female, 1-way 22Fr
• 16936881134507 - PVC Urethral Catheter: 2024-05-07 Female, 1-way 24Fr
• 16936881134514 - PVC Urethral Catheter: 2024-05-07 Pediatric, 1-way 6Fr