VBMax35E 146508

GUDID 00817081020953

VBMax35E, Disposable Pulmonary Function Testing Filter for MEDI, Inc.

A-M SYSTEMS, LLC

Pulmonary function testing filter/mouthpiece

• Primary Device ID: 00817081020953
• NIH Device Record Key: 6ede4b39-0bb9-4eae-ae72-daeffa5e63c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VBMax35E
• Version Model Number: VBMax35E - 146508
• Catalog Number: 146508
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817081020946 [Primary]
GS1	00817081020953 [Package]; Contains: 00817081020946; Package: [50 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: 2017-05-09

On-Brand Devices [VBMax35E]

• 00817081020953: VBMax35E, Disposable Pulmonary Function Testing Filter for MEDI, Inc.
• 00817081026795: VBMax35E