SootheNeb

GUDID 00816042011146

Mesh Nebulizer

FORA CARE INC.

Nebulizing system, non-heated

• Primary Device ID: 00816042011146
• NIH Device Record Key: 803c2de8-7602-478f-96e6-19ffdea50e64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SootheNeb
• Version Model Number: NBL100
• Company DUNS: 004340807
• Company Name: FORA CARE INC.
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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	00816042011146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122060

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-04

On-Brand Devices [SootheNeb]

• 00816042012860: Mouthpiece
• 00816042011474: Medication Cup
• 00816042011467: Mesh Cap
• 00816042011153: Compressor Nebulizer
• 00816042011146: Mesh Nebulizer
• 00816042014659: Compressor Nebulizer
• 00816042014758: Compressor Nebulizer