Healthline, Medicator

GUDID 00850022357756

Convenience Kit: Portless Vinyl Mask (Pediatric) with Adapter (HL-22), Bacterial/Viral Filter, Ultra-Flex tubing (extends 6-24 inches), Aerosol Flow Tee, and End Cap.

Medi/Nuclear Corporation, Inc.

Nebulizing system delivery set, single-use

• Primary Device ID: 00850022357756
• NIH Device Record Key: 5bd25bbc-0bca-4c18-b850-5c09b29a3720
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healthline, Medicator
• Version Model Number: AM-608PK
• 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
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850022357749 [Primary]
GS1	00850022357756 [Package]; Contains: 00850022357749; Package: [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-26
• Device Publish Date: 2022-04-18

On-Brand Devices [Healthline, Medicator ]

• 00850022357756: Convenience Kit: Portless Vinyl Mask (Pediatric) with Adapter (HL-22), Bacterial/Viral Filter,
• 00850022357732: Convenience Kit: Portless Vinyl Mask (Adult) with Adapter (HL-22), Bacterial/Viral Filter, Ultr