Healthline, Medicator Maximizer, Methacholine

GUDID 00857863007789

Methacholine Test Kit, HEPA Filter, 5 Test/CS

Medi/Nuclear Corporation, Inc.

Nebulizing system delivery set, single-use

• Primary Device ID: 00857863007789
• NIH Device Record Key: d85ac961-5c61-4f2f-80b6-ef5d34de1038
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healthline, Medicator Maximizer, Methacholine
• Version Model Number: MCT-5H
• 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	00857863007789 [Primary]

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

Devices Manufactured by Medi/Nuclear Corporation, Inc.

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