Airflow Sensor

Basic Information

• Brand Name: Airflow Sensor
• Primary DI: 00606959010246
• Version / Model: Airflow Sensor Thermistor Pediatrics, 249
• Catalog Number: 1078755
• Company Name: Respironics, Inc.
• Labeler DUNS: 080728314
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-02
• Public Version: 5
• Public Version Date: 2021-03-08
• Public Version Status: Update
• Public Device Record Key: 8a48ba90-4f93-454c-a076-f6cc67f64147

Device Description

Airflow Sensor Thermistor Pediatrics, 249

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: No
• Has Lot/Batch Number: Yes
• 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
BZQ	Monitor, breathing frequency	Anesthesiology	868.2375	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35872	Airway temperature monitoring system	An assembly of devices typically used bedside to continuously measure the temperature at a specific point along a ventilation airway (e.g., inspiratory limb, Y-piece). It typically includes a temperature sensor, a transducer, a cable, and an electronic unit with a display and alarms (audible and/or visual). The system provides real-time information on the temperature of the gases supplied to patients under assisted ventilation, particularly when a heated humidifier is incorporated into the inspiratory line of a patient's breathing circuit.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00606959010246	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K960851	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity