nSpire Health 700-008

GUDID 00852417003255

Wright Respirometer Mk 8

NSPIRE HEALTH LTD

Monitoring spirometer, mechanical

• Primary Device ID: 00852417003255
• NIH Device Record Key: 0fdd2f5f-1ce2-4f42-8686-91f66a436d18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nSpire Health
• Version Model Number: Wright Respirometer Mk 8
• Catalog Number: 700-008
• Company DUNS: 216706895
• Company Name: NSPIRE HEALTH 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: 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	00852417003255 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091853

FDA Product Code

• BZK: Spirometer, Monitoring (W/Wo Alarm)

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: 2017-01-24

On-Brand Devices [nSpire Health]

• 00852417003279: Wright Respirometer Haloscale Standard
• 00852417003262: Wright Respirometer Mk 14
• 00852417003255: Wright Respirometer Mk 8