System One

Basic Information

• Brand Name: System One
• Primary DI: 00606959050754
• Version / Model: 100240B
• Catalog Number: 100240B
• Company Name: Respironics, Inc.
• Labeler DUNS: 080728314
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-18
• Public Version: 1
• Public Version Date: 2019-04-26
• Public Version Status: New
• Public Device Record Key: 2ce5b928-1fd6-4878-a878-7f3419cb2c85

Device Description

System One Bluetooth Accessory Module, China

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: 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
OUG	Medical device data system	General Hospital	880.6310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35477	Clinical laboratory information system	A dedicated assembly of devices designed to electronically receive, collect, store, display, output and distribute clinical laboratory information (e.g., transfer of digital images), within or between healthcare facilities, to support the administrative and clinical activities associated with clinical laboratory services and facilities. Some systems will also assist in data management/analysis. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded, and not directly used to run, steer, or control laboratory analysers or equipment).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00606959050754	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius