DRIVEMEDICAL

Basic Information

• Brand Name: DRIVEMEDICAL
• Primary DI: 00822383534015
• Version / Model: 136DC
• Company Name: Drive Devilbiss Healthcare
• Labeler DUNS: 867673159
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-21
• Public Version: 1
• Public Version Date: 2019-07-01
• Public Version Status: New
• Public Device Record Key: 2895b29f-e748-4d87-a8bb-6f3b122ca44d

Device Description

Patient RoomPatient alarms Product Description: ALARM AC ADAPTER, 1/EA, 25/CV

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
KMI	MONITOR, BED PATIENT	General Hospital	880.2400	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62168	Nurse call system alarm	An electronic device intended to provide an audible sound and/or a visual display, typically coloured flashing lights or scrolling text, to notify a medical professional that (urgent) assistance is needed by a patient. It may be in the form of dome lights, basic visual display screens, and/or beeping devices which are triggered by manual or automatic alert activators (e.g., bedside push-button, ambulatory fall sensor, bed occupancy sensor) [not included]; it may function independently or as a component of a nurse call system via the healthcare facility hardwired or wireless network.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50822383534010	GS1		25	In Commercial Distribution
Primary	00822383534015	GS1
Package	10822383534012	GS1		100	In Commercial Distribution