Aleshon

GUDID 06971209160090

Shenzhen Yuezhongxing Technology Co., Ltd.

Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated

• Primary Device ID: 06971209160090
• NIH Device Record Key: c6a5e3f3-5eb4-48ed-82f4-4ff35d30e1c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aleshon
• Version Model Number: MY126
• Company DUNS: 418012517
• Company Name: Shenzhen Yuezhongxing Technology 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971209160090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201397

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-22
• Device Publish Date: 2022-09-14

On-Brand Devices [Aleshon]

• 06971209160038: W1681
• 06971209160021: W202
• 06971209160014: W203
• 06971209160069: W1681BL
• 06971209160052: W202BL
• 06971209160045: W203BL
• 06971209160076: BM100-EN
• 06971209160090: MY126
• 06971209160083: MY123
• 06971209160182: 222BT
• 06971209160175: 222
• 06971209160168: W1681BT
• 06971209160151: W1681R
• 06971209160144: 121
• 06971209160137: B1683
• 06971209160120: B1682
• 06971209160113: B1681
• 06971209160106: 111