Care Orchestrator

Basic Information

• Brand Name: Care Orchestrator
• Primary DI: 00606959052444
• Version / Model: 1.15
• Catalog Number: 1136537
• Company Name: Respironics, Inc.
• Labeler DUNS: 080728314
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-15
• Public Version: 2
• Public Version Date: 2018-11-08
• Public Version Status: Update
• Public Device Record Key: 45fbe97d-7dc7-4c27-8bbd-c1b0c6afce7b

Device Description

Care Orchestrator Denmark

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: 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
BZD	VENTILATOR, NON-CONTINUOUS (RESPIRATOR)	Anesthesiology	868.5905	2
NOU	CONTINUOUS, VENTILATOR, HOME USE	Anesthesiology	868.5895	2
CBK	VENTILATOR, CONTINUOUS, FACILITY USE	Anesthesiology	868.5895	2
MNT	Ventilator, continuous, minimal ventilatory support, facility use	Anesthesiology	868.5895	2
MNS	VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING	Anesthesiology	868.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57967	Medical equipment clinical data interfacing software	An application software designed for transportation, calculation, aggregation and derivation of data between patient connected medical devices and external information systems used in clinical settings for automating data collection and clinical information management. It is intended to transfer waveform, infusion data, laboratory data from medical devices/lab equipment into an electronic medical record (EMR) or an application for viewing and verification by a clinician. The data can be aggregated for, e.g., patient treatment summary calculations, ordering of infusion solutions/drugs, and laboratory sample tests; it is not primarily intended to manage diagnostic/patient images.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00606959052444	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K152356	000