wellead

GUDID 16944932791876

Cricothyrotomy kit, Type I, Cuffed, 6.0mm DEHP FREE (Sterile)

Well Lead Medical Co.,Ltd

Cricothyrotomy kit, single-use

• Primary Device ID: 16944932791876
• NIH Device Record Key: 05a21fb6-0f5c-47a8-8401-15f0bad9bd37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: wellead
• Version Model Number: 10-0048
• Company DUNS: 544811862
• Company Name: Well Lead Medical Co.,Ltd
• 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: 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	06944932791879 [Primary]
GS1	16944932791876 [Package]; Contains: 06944932791879; Package: Box [10 Units]; In Commercial Distribution
GS1	26944932791873 [Package]; Package: Carton [10 Units]; In Commercial Distribution

FDA Product Code

• OGP: Cricothyrotomy Kit

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: 2021-10-25
• Device Publish Date: 2021-10-15

On-Brand Devices [wellead]

• 16944932791876: Cricothyrotomy kit, Type I, Cuffed, 6.0mm DEHP FREE (Sterile)
• 16944932785127: Endoscopic Seal, Type I (adapter)
• 16944932785110: Endoscopic Seal, Type I