HydroMax 158200

GUDID 00817081020502

HydroMax, Disposable, Heat and Moisture Exchange Filter

A-M SYSTEMS, LLC

Heat/moisture exchanger/microbial filter, non-sterile

• Primary Device ID: 00817081020502
• NIH Device Record Key: 0648622c-d73a-43c8-b3ca-0807a5cef2b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HydroMax
• Version Model Number: HydroMax - 158200
• Catalog Number: 158200
• 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: 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
• 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	00817081020496 [Primary]
GS1	00817081020502 [Package]; Contains: 00817081020496; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130664

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: 2016-09-24

Devices Manufactured by A-M SYSTEMS, LLC

• 00817081028553 - VBMax28s, PF Testing Filter Labeled DR Burton: 2025-08-15 VBMax28s, PF Testing Filter Labeled DR Burton
• 00817081028577 - VBMax28e, PF Testing Filter Labeled DR Burton: 2025-08-15 VBMax28e, PF Testing Filter Labeled DR Burton
• 00817081028515 - VBMAX34, DISPOSABLE PF TESTING FILTER: 2025-07-03 VBMAX34, DISPOSABLE PF TESTING FILTER
• 00817081028539 - PFT KIT J, VBMax34S w/ Blue Rubber Nose clip: 2025-07-03 PFT KIT J, VBMax34S w/ Blue Rubber Nose clip
• 00817081028492 - VBMax34, PF Testing Filter Labeled DR Burton: 2025-06-11 VBMax34, Pulmonary Function Testing Filter Labeled DR Burton
• 00817081028478 - PFT Kit B, VBMax35: 2025-05-20 Pulmonary Function Testing Kit B, VBMax35 with Blue Rubber Pad Nose Clip
• 00817081028454 - PFT Kit J, VBMax31S: 2025-05-12 Pulmonary Function Testing Kit J, VBMax31S with White Rubber Pad Nose Clip
• 00817081028416 - VBMax28, PF Testing Filter: 2025-04-11 VBMax28, Pulmonary Function Testing Filter Labeled DR Burton