VBMax35s, PF Testing Filter Labeled DR Burton 136504

GUDID 00817081028072

VBMax35s, Pulmonary Function Testing Filter Labeled DR Burton

A-M SYSTEMS, LLC

Pulmonary function testing filter/mouthpiece

• Primary Device ID: 00817081028072
• NIH Device Record Key: 3d01a130-d397-4b37-a569-c3d4b65f28aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VBMax35s, PF Testing Filter Labeled DR Burton
• Version Model Number: VBMax35s, DR Burton - 136504
• Catalog Number: 136504
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 3606838300
• Email: sales@a-msystems.com
• Phone: 3606838300
• Email: sales@a-msystems.com
• Phone: 3606838300
• Email: sales@a-msystems.com
• Phone: 3606838300
• Email: sales@a-msystems.com
• Phone: 3606838300
• Email: sales@a-msystems.com
• Phone: 3606838300
• Email: sales@a-msystems.com
• Phone: 3606838300
• Email: sales@a-msystems.com
• Phone: 3606838300
• Email: sales@a-msystems.com
• Phone: 3606838300
• Email: sales@a-msystems.com
• Phone: 3606838300
• Email: sales@a-msystems.com
• Phone: 3606838300
• Email: sales@a-msystems.com
• Phone: 3606838300
• Email: sales@a-msystems.com
• Phone: 3606838300
• Email: sales@a-msystems.com
• Phone: 3606838300
• Email: sales@a-msystems.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817081028065 [Primary]
GS1	00817081028072 [Package]; Contains: 00817081028065; 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: 2025-02-21
• Device Publish Date: 2025-02-13

Devices Manufactured by A-M SYSTEMS, LLC

• 00817081028058 - PFT Kit F, VBMax34E w/ Foam Noseclip: 2025-02-21 Pulmonary Function Test Kit F, VBMax34E w/ Foam Noseclip
• 00817081028072 - VBMax35s, PF Testing Filter Labeled DR Burton: 2025-02-21VBMax35s, Pulmonary Function Testing Filter Labeled DR Burton
• 00817081028072 - VBMax35s, PF Testing Filter Labeled DR Burton: 2025-02-21 VBMax35s, Pulmonary Function Testing Filter Labeled DR Burton
• 00817081028096 - VBMax35, PF Testing Filter: 2025-02-21 VBMax35, Pulmonary Function Testing Filter Labeled DR Burton
• 00817081028119 - VBMax36S, PF Testing Filter Labeled DR Burton: 2025-02-21 VBMax36S, Pulmonary Function Testing Filter Labeled DR Burton
• 00817081028133 - VBMax36E, PF Testing Filter: 2025-02-21 VBMax36E, Pulmonary Function Testing Filter Labeled DR Burton
• 00817081028157 - VBMax36, PF Testing Filter: 2025-02-21 VBMax36, Pulmonary Function Testing Filter Labeled DR Burton
• 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