GUDID 00810021174013

Dongguan SIMZO Electronic Technology Co., Ltd.

Ambulatory nebulizer, non-heated Ambulatory nebulizer, non-heated Ambulatory nebulizer, non-heated Ambulatory nebulizer, non-heated Ambulatory nebulizer, non-heated Ambulatory nebulizer, non-heated Ambulatory nebulizer, non-heated Ambulatory nebulizer, non-heated Ambulatory nebulizer, non-heated Ambulatory nebulizer, non-heated Ambulatory nebulizer, non-heated Ambulatory nebulizer, non-heated Ambulatory nebulizer, non-heated Ambulatory nebulizer, non-heated Ambulatory nebulizer, non-heated Ambulatory nebulizer, non-heated Ambulatory nebulizer, non-heated

• Primary Device ID: 00810021174013
• NIH Device Record Key: edbd6d8e-926f-4142-95f4-11cf9121651e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: NBM-7B
• Company DUNS: 544332470
• Company Name: Dongguan SIMZO Electronic Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	00810021174013 [Primary]
GS1	10810021174010 [Package]; Package: [60 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230379

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: 2024-01-11
• Device Publish Date: 2024-01-03

Devices Manufactured by Dongguan SIMZO Electronic Technology Co., Ltd.

• 00810021174013 - NA: 2024-01-11
• 00810021174013 - NA: 2024-01-11
• 10810021174034 - NA: 2024-01-11
• 00810021171166 - SIMZO: 2021-07-28
• 00810021171173 - SIMZO: 2021-07-28
• 00810021171180 - SIMZO: 2021-07-28
• 00810021171197 - simzo: 2021-07-28
• 00810021171203 - SIMZO: 2021-07-28
• 00810021171210 - SIMZO: 2021-07-28