Thermistor NasalOral, Alice PDx, 220 1143241

GUDID 00606959057487

Respironics, Inc.

Airway temperature monitoring system

Primary Device ID	00606959057487
NIH Device Record Key	d8bb6724-7890-4756-9439-862b72a3e54b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Thermistor NasalOral, Alice PDx, 220
Version Model Number	1143241
Catalog Number	1143241
Company DUNS	080728314
Company Name	Respironics, 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	true
Serial Number	false
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

Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959057487 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K960851

FDA Product Code

BZQ	Monitor, breathing frequency

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	2020-12-23
Device Publish Date	2020-12-15

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