Actiwatch 2

Basic Information

• Brand Name: Actiwatch 2
• Primary DI: 00606959003903
• Version / Model: Actiwatch 2 Communication Dock System
• Catalog Number: 1048092
• Company Name: Respironics, Inc.
• Labeler DUNS: 080728314
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 4
• Public Version Date: 2021-01-26
• Public Version Status: Update
• Public Device Record Key: 0341ae83-2e3a-4f80-9e01-d1bb5384d2a2

Device Description

Actiwatch 2 Communication Dock System

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: 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
GWQ	Full-montage Standard Electroencephalograph	Neurology	882.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36252	Kinesiology ambulatory recorder	A battery-powered device designed to continuously measure and record a patient's kinetic activity during routine ambulation, including monitoring the motion of individual joints/limbs, typically to assess joint mobility, gait performance, and fall-risk or frailty (e.g., during post-surgery rehabilitation). It consists of a motion sensor(s) worn on the torso or a limb (e.g., thigh, calf, wrist, ankle) while performing normal daily activities, and a computing device/software to which body movement signals are transmitted for recording/analysis; it may also be attached to or integrated in an external limb prosthesis for activity monitoring.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00606959003903	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit