Omron Peak A-I-R Peak Flow Meter PF9940

GUDID 00073796699406

Peak Flow Meter for Adult / Pediatric

Omron Healthcare, Inc.

Peak flow meter, manual

• Primary Device ID: 00073796699406
• NIH Device Record Key: aabe1e37-b4e3-4886-9043-7372ce8b1104
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omron Peak A-I-R Peak Flow Meter
• Version Model Number: PF9940
• Catalog Number: PF9940
• Company DUNS: 054318779
• Company Name: Omron Healthcare, 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

Customer Support Contacts

• Phone: 1-800-634-4350
• Email: ohiquality@omron.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796699406 [Primary]
GS1	10073796699403 [Package]; Package: Inner Carton [6 Units]; In Commercial Distribution
GS1	20073796699400 [Package]; Contains: 10073796699403; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982334

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: 2017-05-17

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