QUAKE

Basic Information

• Brand Name: QUAKE
• Primary DI: 00383480000068
• Version / Model: 1297
• Catalog Number: 1297
• Company Name: THAYER MEDICAL CORPORATION
• Labeler DUNS: 626238844
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 4
• Public Version Date: 2021-06-22
• Public Version Status: Update
• Public Device Record Key: 5834dc95-4c27-4d63-a6aa-e417024a29e6

Device Description

QUAKE VIBRATORY PEP DEVICE

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
BYI	Percussor, Powered-Electric	Anesthesiology	868.5665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43947	Positive pressure airway secretion-clearing device	A hand-held, non-powered device designed to remove excessive mucus or sputum (phlegm) from the lungs and upper airways using positive pressure airway (PEP) to treat patients affected by acute or chronic lung disease. PEP is created when a patient exhales into the device which creates vibrations in the chest by various means (e.g., an oscillating ball or creating bubbles in a solution within the device) loosening the mucus for expectoration and assisting in lung expansion. Also known as an oscillating positive expiratory pressure (OPEP) device, it is a single-patient device designed for use both in a healthcare facility and in the home. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10383480000065	GS1	CASE	5	In Commercial Distribution
Primary	00383480000068	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K974849	000