PreciseRx™ Pediatric Flowmeter IRCPF16

GUDID 00850018761291

VENTEC LIFE SYSTEMS, INC.

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• Primary Device ID: 00850018761291
• NIH Device Record Key: fd5f2896-0731-4e60-aedf-61519bc44371
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreciseRx™ Pediatric Flowmeter
• Version Model Number: IRCPF16
• Catalog Number: IRCPF16
• Company DUNS: 078758082
• Company Name: VENTEC LIFE SYSTEMS, 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850018761291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K914488

FDA Product Code

• CAW: Generator, Oxygen, Portable

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: 2023-06-26
• Device Publish Date: 2023-06-16

Devices Manufactured by VENTEC LIFE SYSTEMS, INC.

• 00850018761307 - HomeFill® Oxygen System: 2023-10-24
• 00850018761352 - HomeFill® Oxygen System: 2023-10-24
• 00850018761369 - HomeFill® Oxygen System: 2023-10-24
• 00850018761376 - HomeFill® Oxygen System: 2023-10-24
• 00855573007822 - VOCSN: 2023-07-10
• 00850018761291 - PreciseRx™ Pediatric Flowmeter: 2023-06-26
• 00850018761291 - PreciseRx™ Pediatric Flowmeter: 2023-06-26
• 00855573007761 - VOCSN: 2022-04-20 V+O+C+S+N+Pro, Japanese: The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory supp
• 00855573007785 - VOCSN: 2022-04-20 V+C+Pro, Japanese: The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support fo