PFT Kit A 180051

GUDID 00817081021219

PFT Kit A, 35mm Kit Case

A-M SYSTEMS, LLC

Pulmonary function testing kit

• Primary Device ID: 00817081021219
• NIH Device Record Key: bcca5bcd-51b8-4202-96fd-070da0c236b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PFT Kit A
• Version Model Number: PFT Kit A - 180051
• Catalog Number: 180051
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817081021202 [Primary]
GS1	00817081021219 [Package]; Contains: 00817081021202; Package: [50 Units]; In Commercial Distribution
GS1	00817081021561 [Package]; 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-06
• Device Publish Date: 2017-07-05

On-Brand Devices [PFT Kit A]

• 00817081021219: PFT Kit A, 35mm Kit Case
• 00817081026702: Pulmonary Function Testing Kit A, Disposable, Qty 100, 30 MM O.D., w/ Foam Nose Clips