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

• 00817081027846 - PFT Kit I, VBMax 34s with Nose Clip and Mouthpiece: 2024-10-16 Pulmonary Function Test Kit I, VBMax34S, w/ Blue Rubber Nose Clips & Rubber Mouthpiece
• 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
• 00817081027761 - Pulmonary Function Test Kit J, VBMax30S: 2024-07-10 Pulmonary Function Test Kit J, VBMax30S
• 00817081027747 - PFT KIT F, 31 MM, e-Series, / Blue Foam Nose Clips: 2024-07-04 Pulmonary Function Test Kit F, 31 MM O.D., e-Series, / Blue Foam Nose Clips
• 00817081027709 - Pulmonary Function Test Kit B, 33mm VBMAX: 2024-03-25 Pulmonary Function Test Kit B, Disposable, Qty 100, 33 MM O.D. W/ Blue Foam Nose Clip