FUTUREMED 39XXX-02E

GUDID 00853452007314

Futuremed Spirometry Filter with oval mouthpiece for use with pulmonary function testing equipment. 35mm OD.

FUTUREMED AMERICA, INC.

Pulmonary function testing filter/mouthpiece

• Primary Device ID: 00853452007314
• NIH Device Record Key: 8cb275a2-c33a-4726-85c9-88d0bef9c68c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FUTUREMED
• Version Model Number: Size 2 Oval PFT Filter
• Catalog Number: 39XXX-02E
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853452007307 [Primary]
GS1	00853452007314 [Package]; Contains: 00853452007307; Package: Case of 200 [200 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: 2017-10-24

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