Percussionaire

Basic Information

• Brand Name: Percussionaire
• Primary DI: 00849436000198
• Version / Model: F00008-1FR
• Catalog Number: S00018-1FR
• Company Name: PERCUSSIONAIRE CORPORATION
• Labeler DUNS: 603048778
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-22
• Public Version: 2
• Public Version Date: 2022-03-11
• Public Version Status: Update
• Public Device Record Key: 8faf7c86-e2df-4869-b6e5-5957443c2713
• Distribution End Date: 2022-03-04

Device Description

VDR4 - French

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
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	868.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59942	Stationary pneumatic high-frequency ventilator	A pneumatically-powered automatic cycling machine designed for static use and intended to assist or control alveolar ventilation using a frequency that is considerably higher than the physiological breathing rate and a tidal volume less than or equal to the anatomic dead space. The device will typically function independently or may be used in conjunction with an intensive care ventilator to superimpose its high frequency percussive ventilation on top of a normal ventilation frequency. It is typically used in critical care situations on patients with respiratory disease requiring ventilatory assistance, typically through an artificial airway [e.g., endotracheal (ET) tube or tracheostomy].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10849436000195	GS1	Case	1	Not in Commercial Distribution	2022-03-04
Primary	00849436000198	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K905235	000