Airpulse

GUDID 00198715785128

Dongguan SIMZO Electronic Technology Co., Ltd.

Therapeutic agent nebulizer, ambulatory

• Primary Device ID: 00198715785128
• NIH Device Record Key: a6142e35-3644-4cb8-8924-1b0d328f9bbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Airpulse
• Version Model Number: NBM-6B
• 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	00198715785128 [Primary]

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: 2026-01-12
• Device Publish Date: 2026-01-02

On-Brand Devices [Airpulse]

• 00810021174259: NBM-6B
• 00198715785128: NBM-6B