PFT Kit E, VBMax31E 189111

GUDID 00817081027525

Pulmonary Function Testing Kit E, VBMax31E, with Blue Rubber Nose Clip & 164900 Mouthpiece

A-M SYSTEMS, LLC

Pulmonary function testing kit

• Primary Device ID: 00817081027525
• NIH Device Record Key: 9ce80372-b4e6-489e-94c7-2d554dde9673
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PFT Kit E, VBMax31E
• Version Model Number: Kit E, VBMax31E, 189111
• Catalog Number: 189111
• 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: true
• 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	00817081027518 [Primary]
GS1	00817081027525 [Package]; Contains: 00817081027518; 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: 2023-04-04
• Device Publish Date: 2023-03-27

Devices Manufactured by A-M SYSTEMS, LLC

• 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
• 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