MiniBox PUO-MiniBox

GUDID 07290016675009

The MiniBox is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes ). The MiniBox i

PULMONE ADVANCED MEDICAL DEVICES LTD

Pulmonary function analysis system, adult

• Primary Device ID: 07290016675009
• NIH Device Record Key: d8139997-5385-43f0-8345-e501b13de4fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiniBox
• Version Model Number: MiniBox
• Catalog Number: PUO-MiniBox
• Company DUNS: 514812275
• Company Name: PULMONE ADVANCED MEDICAL DEVICES LTD
• 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: 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	07290016675009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141793

FDA Product Code

• BZC: Calculator, Pulmonary Function Data

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: 2016-09-24

Devices Manufactured by PULMONE ADVANCED MEDICAL DEVICES LTD

• 07290016675009 - MiniBox: 2018-07-06The MiniBox is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes ). The MiniBox i
• 07290016675009 - MiniBox: 2018-07-06 The MiniBox is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung vo
• 07290016675016 - MiniBox+: 2018-07-06 The PulmOne MiniBox+ is intended to measure lung function in adult and pediatric patients, 5 years and older, while at rest (inc