IntelliVue CL Respiration Pod

Basic Information

• Brand Name: IntelliVue CL Respiration Pod
• Primary DI: 00884838020689
• Version / Model: IntelliVue CL Respiration Pod
• Catalog Number: 865218
• Company Name: Philips Medizin Systeme Böblingen GmbH
• Labeler DUNS: 314101143
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-28
• Public Version: 6
• Public Version Date: 2022-08-12
• Public Version Status: Update
• Public Device Record Key: 78f88cce-8717-4d5e-825c-e4aa46b7fb85

Device Description

IntelliVue Cableless Respiration Pod, a battery-powered respiration device for frequent Cableless Monitoring of patients. The IntelliVue CL Respiration Pod provides the respiration rate and optional the pulse rate via short range radio to the receiving system.

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
BZQ	Monitor, breathing frequency	Anesthesiology	868.2375	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12662	Respiration monitor	A mains electricity (AC-powered) bedside device designed to measure and display a non-ambulatory patient's respiratory functions. Measurements include concentration of respiratory gas components [e.g., carbon dioxide (CO2), oxygen (O2)] and/or continuous monitoring of the inspiration/expiration cycle including respiration rate, air volume, and cessation of breathing (apnoea). The device may also measure airway pressure (Paw) and oesophageal pressure (Pes). It is typically equipped with audible and/or visual alarms that are triggered when respiratory parameters drop below or exceed pre-set limits.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838020689	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 57 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity