PFT Kit E, 36mm e-Series Kit 189136

GUDID 00817081021660

Pulmonary Function Test Kit E, 36mm e-Series Kit

A-M SYSTEMS, LLC

Pulmonary function testing kit

• Primary Device ID: 00817081021660
• NIH Device Record Key: d874574c-3fad-46bb-93ac-57895237c090
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PFT Kit E, 36mm e-Series Kit
• Version Model Number: PFT Kit E, 36mm Kit - 189136
• Catalog Number: 189136
• 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	00817081021660 [Package]; Contains: 00817081021684; Package: [100 Units]; In Commercial Distribution
GS1	00817081021684 [Primary]

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: 2019-03-19
• Device Publish Date: 2019-03-11

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