SpiroFlow E5010-2-NOV

GUDID 00855784004245

Adult Peak Flow Meter

Spirometrics

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• Primary Device ID: 00855784004245
• NIH Device Record Key: ae0e040a-10b7-4b40-885f-65ec6c8a7d96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpiroFlow
• Version Model Number: E5010
• Catalog Number: E5010-2-NOV
• Company DUNS: 830864406
• Company Name: Spirometrics
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 207-657-6700
• Email: info@spirometrics.com
• Phone: 207-657-6700
• Email: info@spirometrics.com
• Phone: 207-657-6700
• Email: info@spirometrics.com
• Phone: 207-657-6700
• Email: info@spirometrics.com
• Phone: 207-657-6700
• Email: info@spirometrics.com
• Phone: 207-657-6700
• Email: info@spirometrics.com
• Phone: 207-657-6700
• Email: info@spirometrics.com
• Phone: 207-657-6700
• Email: info@spirometrics.com
• Phone: 207-657-6700
• Email: info@spirometrics.com
• Phone: 207-657-6700
• Email: info@spirometrics.com
• Phone: 207-657-6700
• Email: info@spirometrics.com
• Phone: 207-657-6700
• Email: info@spirometrics.com
• Phone: 207-657-6700
• Email: info@spirometrics.com
• Phone: 207-657-6700
• Email: info@spirometrics.com
• Phone: 207-657-6700
• Email: info@spirometrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855784004245 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K915059

FDA Product Code

• BZH: Meter, Peak Flow, Spirometry

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: 2016-10-11

On-Brand Devices [SpiroFlow]

• 00855784004252: Child Peak Flow Meter
• 00855784004245: Adult Peak Flow Meter
• 00855784004054: Child Peak Flow Meter
• 00855784004030: Adult Peak Flow Meter