Percussionaire

Basic Information

• Brand Name: Percussionaire
• Primary DI: 00849436000358
• Version / Model: F00012-HT
• Catalog Number: S00009
• Company Name: PERCUSSIONAIRE CORPORATION
• Labeler DUNS: 603048778
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-21
• Public Version: 5
• Public Version Date: 2021-07-15
• Public Version Status: Update
• Public Device Record Key: eb928ab6-7a6b-4a57-bc6b-c08a98c0c3a6
• Distribution End Date: 2021-07-14

Device Description

IPV HC 115V

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: Yes
• Has Lot/Batch Number: No
• 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
NHJ	Device, Positive Pressure Breathing, Intermittent	Anesthesiology	868.5905	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59943	Portable pneumatic high-frequency ventilator	A pneumatically-powered device designed to be easily moved/mounted and intended to provide long-term support or therapeutic alveolar ventilation for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs using a frequency that is considerably higher than physiological breathing rates and a tidal volume less than or equal to the anatomic dead space (percussive ventilation), typically through an endotracheal (ET) tube, tracheostomy cannula, or mask. It typically includes a control system and alarms, sometimes with additional features (e.g., humidification).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00849436000358	GS1
Package	10849436000355	GS1	Case	1	Not in Commercial Distribution	2021-07-14

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K905236	000