*Mini-Heart® Lo-Flo Continuous Nebulizer W/Extension Set,7'

GUDID 10709078000215

*Mini-Heart® Lo-Flo Continuous Nebulizer W/Extension Set,7'

WESTMED, INC.

Nebulizing system delivery set, single-use

• Primary Device ID: 10709078000215
• NIH Device Record Key: 9f5b0f58-d7eb-45a6-9da1-a54310fe932d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: *Mini-Heart® Lo-Flo Continuous Nebulizer W/Extension Set,7'
• Version Model Number: 100616
• 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	00709078000218 [Primary]
GS1	10709078000215 [Package]; Contains: 00709078000218; 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: 2017-01-06