Resp-O2 Peak Flow Meter

GUDID 00840117318786

Resp-P2 Peak Flow Meter Low Range 50-300 l/min; Pediatric

DYNAREX CORPORATION

Inspiratory peak flow meter

• Primary Device ID: 00840117318786
• NIH Device Record Key: c71c76ca-e930-4a00-8a2f-093035de228f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2 Peak Flow Meter
• Version Model Number: 36110
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840117318786 [Package]; Contains: 00840117319035; Package: Case [10 Units]; In Commercial Distribution
GS1	00840117319035 [Primary]

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: 2021-04-30
• Device Publish Date: 2021-04-22

On-Brand Devices [Resp-O2 Peak Flow Meter]

• 00840117318793: Resp-O2 Peak Flow Meters Full Range 50-800 l/min
• 00840117318786: Resp-P2 Peak Flow Meter Low Range 50-300 l/min; Pediatric