Healthline, Medicator Maximizer

GUDID 00857863007802

Medicator Maximizer+Plus, No Neb, HEPA Filter

Medi/Nuclear Corporation, Inc.

Nebulizing system delivery set, single-use

• Primary Device ID: 00857863007802
• NIH Device Record Key: e06d8145-1d46-456a-bcb1-d015652b183a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healthline, Medicator Maximizer
• Version Model Number: AM-603H
• Company DUNS: 079628327
• Company Name: Medi/Nuclear Corporation, 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: true
• Device Combination Product: false
• Single Use: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-321-5981
• Email: cs@medinuclear.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857863007734 [Primary]
GS1	00857863007802 [Package]; Contains: 00857863007734; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960397

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: 2017-06-09

On-Brand Devices [Healthline, Medicator Maximizer]

• 00857863007802: Medicator Maximizer+Plus, No Neb, HEPA Filter
• 10857863007724: Medicator Maximizer+Plus HEPA