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 Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult 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