Balnore

GUDID 16956937005223

Shenzhen Homed Medical Device Co., Ltd.

Therapeutic agent nebulizer, benchtop

• Primary Device ID: 16956937005223
• NIH Device Record Key: 1d3601c9-d9e4-4149-a73e-9116cd2aa0ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Balnore
• Version Model Number: JLN-2361Air
• Company DUNS: 421309081
• Company Name: Shenzhen Homed Medical Device Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06956937005226 [Primary]
GS1	16956937005223 [Package]; Contains: 06956937005226; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161586

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: 2025-10-03
• Device Publish Date: 2025-09-25

Devices Manufactured by Shenzhen Homed Medical Device Co., Ltd.

• 16956937002550 - Luminvia: 2025-10-03
• 16956937005223 - Balnore: 2025-10-03
• 16956937005223 - Balnore: 2025-10-03
• 06956937002850 - Homed: 2025-03-18
• 06956937001457 - Curelief: 2020-03-23 Portable vibrating mesh nebulizer