VBMax30S 136307

GUDID 00817081020892

VBMax30S, Disposable Pulmonary Function Testing Filter

A-M SYSTEMS, LLC

Pulmonary function testing filter/mouthpiece

• Primary Device ID: 00817081020892
• NIH Device Record Key: 9e92fbc8-4944-4f05-a8df-d37857f48dde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VBMax30S
• Version Model Number: VBMax30S - 136307
• Catalog Number: 136307
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 3606808300
• Email: sales@a-msystems.com
• Phone: 3606808300
• Email: sales@a-msystems.com
• Phone: 3606808300
• Email: sales@a-msystems.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817081020885 [Primary]
GS1	00817081020892 [Package]; Contains: 00817081020885; 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-29

Devices Manufactured by A-M SYSTEMS, LLC

• 00817081027952 - VBMax30S, PF Testing Filter Labeled DR Burton: 2025-02-04 VBMax30S, Pulmonary Function Testing Filter, Labeled DR Burton
• 00817081027976 - VBMax30E, PF Testing Filter: 2025-02-04 VBMax30E, Pulmonary Function Testing Filter, Labeled DR Burton
• 00817081027990 - VBMax30, PF Testing Filter: 2025-02-04 VBMax30, Pulmonary Function Testing Filter, Labeled DR Burton
• 00817081028010 - VBMax34S, PF Testing Filter Labeled DR Burton: 2025-02-04 VBMax34S, Pulmonary Function Testing Filter Labeled DR Burton
• 00817081028034 - VBMax34E, PF Testing Filter Labeled DR Burton: 2025-02-04 VBMax34E, Pulmonary Function Testing Filter Labeled DR Burton
• 00817081027914 - 3 Liter Aluminum Calibration Syringe w/ Adapter: 2024-11-15 3 Liter Aluminum Calibration Syringe w/ Adapter
• 00817081027884 - PFT Kit A, 28MM O.D: 2024-11-01 Pulmonary Function Test Kit A, 28MM O.D., W/Foam Nose Clip & Rubber Mouthpiece
• 00817081027907 - PFT Kit J, VBMax36S: 2024-11-01 Pulmonary Function Test Kit J, VBMax36S with Blue Foam Nose Clip