- Physicians Office Resource

Filter 22mm .2micron PVC
Sensor - Filter 22mm .2micron PVC

Device Description

A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as "nasal prongs". This is a single-use device.

Environmental Conditions

Storage Environment Humidity - Percent (%) Relative Humidity

95.00
15.00

Storage Environment Temperature - Degrees Fahrenheit

140.00
-4.00

Storage Environment Temperature - Degrees Celsius

60.00
-20.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: OLV

Device Name: Standard Polysomnograph With Electroencephalograph

Device Class: 2

Physical State: May include standard polysomnography recording hardware (e.g. headbox, cables, computer, monitor, wireless) and basic software (e.g. used to display, store, archive, or manually annotate data). Does NOT include electrodes, vital signs monitors, polysomnography devices without electroencephalograph, more complex software used to analyze electroencephalograph data or software used to automatically detect events.

Definition: Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.

Submission Type ID: 1

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Uses electrodes placed on the scalp, within the brain, or other locations, via user-specified locations, to record and display electrical activity of the brain and other organs

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Brain

Regulation Number: 882.1400

Third Party Flag: Y

Medical Specialty: NE

Device Identifiers

Device Id: 40606959033236

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00606959033238

Package Quantity: 10

Package Discontinue Date: 12/31/1999 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Multipack

Device Id: 00606959033238

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 30606959033239

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00606959033238

Package Quantity: 50

Package Discontinue Date: 12/31/1999 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Multipack

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