VBMax PFT Kit I 187165

GUDID 00817081022537

PFT Kit I, VBMax35S w/ Blue Foam Nose Clip and Rubber Mouthpiece

A-M SYSTEMS, LLC

Pulmonary function testing kit

• Primary Device ID: 00817081022537
• NIH Device Record Key: 52092440-fe8f-4080-bba8-2eacab1b8ecc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VBMax PFT Kit I
• Version Model Number: VBMax PFT Kit I - 187165
• Catalog Number: 187165
• 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	00817081022520 [Primary]
GS1	00817081022537 [Package]; Contains: 00817081022520; 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: 2019-08-13
• Device Publish Date: 2019-08-05

Devices Manufactured by A-M SYSTEMS, LLC

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• 00817081027860 - PFT KIT J, VBMax35S, w/ Foam Nose Clip: 2024-10-16 Pulmonary Function Test Kit J, VBMax35S, w/ Foam Nose Clip
• 00817081027822 - PFT Kit A, 48 MM O.D.: 2024-09-30 PFT Kit A, 48 MM O.D.
• 00817081027808 - PFT KIT F, VBMax36S w/ Rubber Nose Clips: 2024-09-16 Pulmonary Function Test Kit F, VBMax36S with Rubber Nose Clips
• 00817081027785 - PFT Kit I, VBMax35S, w/ White Foam Nose Clips: 2024-07-18 Pulmonary Function Test Kit I, VBMax35S, w/ White Foam Nose Clips