Invacare® PreciseRx™ Pediatric Flowmeter

Basic Information

• Brand Name: Invacare® PreciseRx™ Pediatric Flowmeter
• Primary DI: 00841447100157
• Version / Model: IRCPF16
• Catalog Number: IRCPF16
• Company Name: INVACARE CORPORATION
• Labeler DUNS: 076916246
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-14
• Public Version: 7
• Public Version Date: 2023-09-20
• Public Version Status: Update
• Public Device Record Key: 37846231-6a02-49cf-a4a3-308f0a8f2c18
• Distribution End Date: 2022-11-21

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAW	Generator, Oxygen, Portable	Anesthesiology	868.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61365	Medical gas flowmeter, Thorpe tube	A device intended to measure and regulate the flow of a medical gas [e.g., oxygen (O2), carbon dioxide (CO2), nitrous oxide (N2O), helium/oxygen gas mixture (heliox), medical air] during various procedures (e.g., therapeutic administration, anaesthesia, insufflation during surgery). It consists of an upright tube containing a float, which rises and falls in relation to gas flow, and a distal valve (compensated flowmeter) to control gas flow rate; some types include a pressure gauge/regulator. It will be calibrated to a specific medical gas and have a dedicated flow rate range, therefore some types may be dedicated to a specific patient group (e.g., neonate, infant, adult) or clinical use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841447100157	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -29 – 158 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -29 – 158 Degrees Fahrenheit