inCourage®

Basic Information

• Brand Name: inCourage®
• Primary DI: 00841561102792
• Version / Model: 500040-001
• Company Name: RESPIRATORY TECHNOLOGIES, INC.
• Labeler DUNS: 847990566
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-21
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: b3e41ae7-a151-4c10-b081-53d96da6535d

Device Description

Facility Cart, Cool Grey

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: 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
36801	Utility trolley	A cart designed for transporting/supplying general-purpose goods, devices, medical equipment, or supplies within a hospital/institution department or ward. This trolley (cart) may have one or more open platforms and may have a handle(s) for pushing the trolley.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841561102792	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K051383	000