PFT Kit B, 35MM 180112

GUDID 00817081021943

Pulmonary Function Testing Kit B, 35MM O.D. w/ Foam Nose Clip

A-M SYSTEMS, LLC

Pulmonary function testing kit

• Primary Device ID: 00817081021943
• NIH Device Record Key: 856ea1b0-ecea-4806-bc6c-4e116fea49a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PFT Kit B, 35MM
• Version Model Number: PFT Kit B, 35MM - 180112
• Catalog Number: 180112
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817081021936 [Primary]
GS1	00817081021943 [Package]; Contains: 00817081021936; 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: 2019-03-20
• Device Publish Date: 2019-03-12

On-Brand Devices [PFT Kit B, 35MM]

• 00817081022643: PFT Kit B, 35MM O.D. w/ Foam Nose Clip and elliptical mouthpiece
• 00817081021943: Pulmonary Function Testing Kit B, 35MM O.D. w/ Foam Nose Clip