PFT Kit A, Disposable, 28MM OD Filter 181128

GUDID 00817081023701

PFT Kit A, Disposable, 28MM OD Filter

A-M SYSTEMS, LLC

Pulmonary function testing kit

• Primary Device ID: 00817081023701
• NIH Device Record Key: 6ffac4ff-7327-485b-972f-4f2a4d032252
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PFT Kit A, Disposable, 28MM OD Filter
• Version Model Number: PFT Kit A, 28MM OD Filter - 181128
• Catalog Number: 181128
• Company DUNS: 020275145
• Company Name: A-M SYSTEMS, LLC
• 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: 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	00817081023695 [Primary]
GS1	00817081023701 [Package]; Contains: 00817081023695; Package: [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000654

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

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: 2020-01-13
• Device Publish Date: 2020-01-03

Devices Manufactured by A-M SYSTEMS, LLC

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• 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
• 00817081028218 - PFT Nose Clip with Foam Pads: 2025-02-28 Disposable White Pulmonary Function Testing Nose Clip with Foam Pads
• 00817081028195 - Pulmonary Function Test Kit E: 2025-02-26 Pulmonary Function Test Kit E, VBMax35E W/ Foam Nose Clip & 1649, Labeled D R Burton