Invacare® PreciseRx™ Pediatric Flowmeter IRCPF16

GUDID 00841447100157

INVACARE CORPORATION

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• Primary Device ID: 00841447100157
• NIH Device Record Key: 37846231-6a02-49cf-a4a3-308f0a8f2c18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invacare® PreciseRx™ Pediatric Flowmeter
• Version Model Number: IRCPF16
• Catalog Number: IRCPF16
• Company DUNS: 076916246
• Company Name: INVACARE CORPORATION
• 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

Customer Support Contacts

• Phone: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841447100157 [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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-07
• Device Publish Date: 2015-09-14

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• 00841447103332 - Invacare® HomeFill® Cylinder Bag: 2024-04-18 Invacare HF2PC9BAG Home Fill M9 Cylinder Bag
• 00841447103349 - Invacare® HomeFill® Cylinder Bag: 2024-04-18 Invacare HF2PCL6BAG Home Fill ML6 Cylinder Bag
• 00841447103356 - Invacare® HomeFill® Cylinder Bag: 2024-04-18 Invacare HF2POST6BAG Home Fill ML6 Post Valve Cylinder Bag
• 00841447103363 - Invacare® HomeFill® Cylinder Bag: 2024-04-18 Invacare HF2POST9BAG Home Fill M9 Post Valve Cylinder Bag
• 00841447103370 - Invacare® Platinum® 10 Oxygen Concentrator: 2024-04-18 Invacare IRC10LXO2 Platinum 10 Oxygen Concentrator
• 00841447103387 - Invacare® Perfecto2™ V Oxygen Concentrator: 2024-04-18 Invacare IRC5PO2V Perfecto2 V Oxygen Concentrator