SpiroFlow E5020-2

GUDID 00855784004054

Child Peak Flow Meter

Spirometrics

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• Primary Device ID: 00855784004054
• NIH Device Record Key: b61be997-e0a4-48fd-b3e5-7bdf5d066c18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpiroFlow
• Version Model Number: E5020
• Catalog Number: E5020-2
• 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: true
• 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	00855784004047 [Primary]
GS1	00855784004054 [Package]; Contains: 00855784004238; Package: box [2 Units]; In Commercial Distribution
GS1	00855784004061 [Package]; Contains: 00855784004238; Package: box [8 Units]; In Commercial Distribution
GS1	00855784004238 [Package]; Contains: 00855784004047; Package: box [12 Units]; In Commercial Distribution

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