PFT KIT A, 30MM OD FILTER 181101

GUDID 00817081021851

Pulmonary Function Testing KIT A, 30MM OD FILTER

A-M SYSTEMS, LLC

Pulmonary function testing kit

• Primary Device ID: 00817081021851
• NIH Device Record Key: 227b7972-9f00-4eb7-86f9-4f0928311e3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PFT KIT A, 30MM OD FILTER
• Version Model Number: PFT KIT A, 30MM FILTER - 181101
• Catalog Number: 181101
• 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: 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: 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	00817081021844 [Primary]
GS1	00817081021851 [Package]; Contains: 00817081021844; 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: 2019-03-20
• Device Publish Date: 2019-03-12

Devices Manufactured by A-M SYSTEMS, LLC

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• 00817081028430 - PFT Kit B, VBMax35 w/ Blue Foam Nose clip: 2025-04-11 Pulmonary Function Test Kit B, VBMax35 w/ Blue Foam Nose clip
• 00817081028393 - PFT Kit I, VBMax36S w/ Foam Nose Clip and 164900: 2025-04-10 Pulmonary Function Test Kit I, VBMax36S w/ Foam Nose Clip and 164900, Labeled DR Burton
• 00817081028379 - PFT Kit B, VBMax48: 2025-04-01 Pulmonary Function Test Kit B, VBMax48 w/ Rubber Nose clip and Tube Mouthpiece
• 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