Nebulizer, Side Stream, Re-Usable 166112

GUDID 00817081026344

Nebulizer, Side Stream, Re-Usable

A-M SYSTEMS, LLC

Nebulizing system delivery set, single-use

• Primary Device ID: 00817081026344
• NIH Device Record Key: 67cc85b2-ba4b-4e80-8705-fc6881778cb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nebulizer, Side Stream, Re-Usable
• Version Model Number: Nebulizer, Side Stream, Re-Usable - 166112
• Catalog Number: 166112
• Company DUNS: 020275145
• Company Name: A-M SYSTEMS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 3606838300
• Email: sales@a-msystems.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817081026344 [Primary]

FDA Product Code

• EPN: Pump, Nebulizer, Manual

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: 2020-04-17
• Device Publish Date: 2020-04-09

Devices Manufactured by A-M SYSTEMS, LLC

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• 00817081028355 - Pulmonary Function Test Kit E: 2025-03-10 Pulmonary Function Test Kit E, VBMax34E w/ Foam Nose Clip and Rubber Mouthpiece
• 00817081028270 - PFT Kit E, VBMax36E: 2025-03-05 Pulmonary Function Testing Kit E, VBMax36E W/ Foam Nose Clip & 1649, Labeled D R Burton
• 00817081028294 - Disposable White PFT Nose Clip with Rubber Pads, Labeled D R Burton: 2025-03-05 Disposable White Pulmonary Function Testing Nose Clip with Rubber Pads, Labeled D R Burton
• 00817081028317 - Disposable Blue PFT Nose Clip with Rubber Pads: 2025-03-05 Disposable Blue Pulmonary Function Testing Nose Clip with Rubber Pads, Labeled D R Burton
• 00817081028331 - Disposable Blue PFT Nose Clip with Foam Pads: 2025-03-05 Disposable Blue PFT Nose Clip with Foam Pads, Labeled D R Burton
• 00817081028232 - Mouthpiece, Disposable, White, Thermoplastic, Bite Block Style: 2025-03-03 Mouthpiece, Disposable, White, Thermoplastic, Bite Block Style, D R Burton
• 00817081028256 - Breathebite Mouthpiece, Disposable, Thermoplastic, Tongue Depressing: 2025-03-03 Breathebite Mouthpiece, Disposable, White, Thermoplastic, Tongue Depressing, D R Burton