Mini-HEART®

GUDID 00709078000232

Hi-Flo Continuous Nebulizer

WESTMED, INC.

Nebulizing system delivery set, single-use

• Primary Device ID: 00709078000232
• NIH Device Record Key: 59344a8c-63b1-438e-8bdc-5ef62f1960ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mini-HEART®
• Version Model Number: 100612
• Company DUNS: 092673953
• Company Name: WESTMED, 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00709078000232 [Primary]
GS1	10709078000239 [Package]; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K920443

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: 2016-12-22

On-Brand Devices [Mini-HEART®]

• 00709078000263: Hi-Flo Continuous Nebulizer, Super Spike Mask, 7'
• 00709078000256: Hi-Flo Continuous Nebulizer, Pediatric Aerosol Mask, 7'
• 00709078000249: Hi-Flo Continuous Nebulizer, Adult Aerosol Mask, 7'
• 00709078000232: Hi-Flo Continuous Nebulizer