Clever Choice Peak Flow Meter 50002-0860-38

GUDID 00850002860382

Clever Choice Peak Flow Meter 50-800 L/Min Adult and Child Mouthpieces included

SIMPLE DIAGNOSTICS INC

Peak flow meter, manual

• Primary Device ID: 00850002860382
• NIH Device Record Key: e000aa60-9da1-457e-884b-18811a2ae305
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clever Choice Peak Flow Meter
• Version Model Number: SDI-PFM
• Catalog Number: 50002-0860-38
• Company DUNS: 004135503
• Company Name: SIMPLE DIAGNOSTICS INC
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850002860382 [Primary]
GS1	10850002860389 [Package]; Package: Case [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172804

FDA Product Code

• BZH: Meter, Peak Flow, Spirometry

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-12
• Device Publish Date: 2019-11-04

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