3 Liter Aluminum Calibration Syringe w/ Adapter 192711

GUDID 00817081027914

3 Liter Aluminum Calibration Syringe w/ Adapter

A-M SYSTEMS, LLC

Spirometer/pulmonary function analyser syringe

• Primary Device ID: 00817081027914
• NIH Device Record Key: 4c5ccf8e-63b4-4a63-b17e-3668db1bdbff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3 Liter Aluminum Calibration Syringe w/ Adapter
• Version Model Number: 3 Liter Calibration Syringe - 192711
• Catalog Number: 192711
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817081027914 [Primary]

FDA Product Code

• BXW: Calibrator, Volume, Gas

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: 2024-11-15
• Device Publish Date: 2024-11-07

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