AccessGUDID - DEVICE: Care Orchestrator Essence (00606959052833)

GUDID

Device Identifier (DI) Information

Brand Name: Care Orchestrator Essence
Version or Model: 2.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1135709
Company Name: Respironics, Inc.

Primary DI Number: 00606959052833
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080728314 *Terms of Use

Device Description: Care Orchestrator Essence, Clinical data collection management information system application software

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNT	Ventilator, continuous, minimal ventilatory support, facility use
BZD	VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
MNS	VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
NOU	CONTINUOUS, VENTILATOR, HOME USE
CBK	VENTILATOR, CONTINUOUS, FACILITY USE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152356	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 69ae5cff-3a01-4096-a481-11ccc6b0a80f
Public Version Date: November 08, 2018
Public Version Number: 2
DI Record Publish Date: August 21, 2018