45710

45710
AIM - 4500

An electronic device intended to be used in the assessment and training of a patient's inhalation flow rates and "firing" coordination when using an aerosol metered dose inhaler (MDI) or a dry powder inhaler (DPI). It is typically known as an aerosol inhalation monitor (AIM), and includes a display/control panel, an electronic flowmeter, a placebo MDI aerosol canister, and a flowhead with mouthpiece. The patient demonstrates his/her inhalation technique while the healthcare provider observes their performance; a visual incentive training device to encourage and motivate the patient, especially children, may be included.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: BWF

Device Name: Spirometer, Therapeutic (Incentive)

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: AN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 868.5690

Third Party Flag: Y

Medical Specialty: AN

Device Id: 35099169457103

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 05099169457102

Package Quantity: 25

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 05099169457102

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 15099169457109

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 15099169457109

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