AccessGUDID - DEVICE: DreamStation (00606959022867)

GUDID

Device Identifier (DI) Information

Brand Name: DreamStation
Version or Model: DreamStation Cellular Modem with Oximetry, PRI, EU
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 100620C
Company Name: Respironics, Inc.

Primary DI Number: 00606959022867
Issuing Agency: GS1
Commercial Distribution End Date: October 28, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 080728314 *Terms of Use

Device Description: DreamStation Cellular Modem with Oximetry, Europe, with PRI Label, Rental

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?
32547	Medical networking interface unit	An electronic unit or device assembly intended to be used to interface one or more noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor/monitoring system) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be an ethernet router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUG	Medical device data system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6eb861c9-cf66-42b3-8dbe-53c4d1aac2af
Public Version Date: October 31, 2022
Public Version Number: 6
DI Record Publish Date: September 18, 2016