FUTUREMED

GUDID 00853452007024

SPIROVISION PC BASED SPIROMETER

FUTUREMED AMERICA, INC.

Diagnostic spirometer

• Primary Device ID: 00853452007024
• NIH Device Record Key: b3122f21-5b1a-4c1c-a06f-10c1cf807997
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FUTUREMED
• Version Model Number: SpiroVision
• Company DUNS: 195929658
• Company Name: FUTUREMED AMERICA, INC.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853452007024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953948

FDA Product Code

• BZG: Spirometer, Diagnostic

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: 2017-10-24

On-Brand Devices [FUTUREMED]

• 00853452007413: Futuremed spirometry filter with round mouthpiece, for use with pulmonary function equipment. 48
• 00853452007314: Futuremed Spirometry Filter with oval mouthpiece for use with pulmonary function testing equipme
• 00853452007208: Futuremed spirometry filter with round mouthpiece for use with pulmonary function testing equipm
• 00853452007185: Futuremed Spirometry filter with oval mouthpiece, for use with pulmonary function testing equipm
• 00853452007024: SPIROVISION PC BASED SPIROMETER
• 00853452007017: Futuremed Discovery-2 diagnostic spirometer