Medex - 22-7500
Device Description
A mask placed over the nose/mouth designed to create resistance for a patient's airway while inhaling and/or exhaling during respirations to strengthen and rehabilitate the respiratory muscles. It typically creates resistance through a mechanical means (e.g., a spring-loaded valve) that can be adjusted to provide progressive training. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: ION
Device Name: Exerciser, Non-Measuring
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: PM
Review Code: N/A
Technical Method: Y
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 890.5370
Third Party Flag: N
Medical Specialty: PM
Device IdentifiersDevice Id: 50788942275001
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00788942275006
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case
Device Id: 00788942275006
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
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