AccessGUDID - DEVICE: Remote Alarm Device (00884838057371)

GUDID

Device Identifier (DI) Information

Brand Name: Remote Alarm Device
Version or Model: Remote Alarm Device
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 866406
Company Name: Philips Medizin Systeme Böblingen GmbH

Primary DI Number: 00884838057371
Issuing Agency: GS1
Commercial Distribution End Date: March 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 314101143 *Terms of Use

Device Description: The IntelliVue Remote Alarm Device (866406) provides audible and visual alarm information at a remote location. It is compatible with the MX series of patient monitors starting with the MX400.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
62911	Physiologic monitoring system alarm	An electronic device intended to be connected to a physiologic monitoring system to provide an audible and/or visual indicator, in the event of out-of-range parameter detection, to notify medical staff that (urgent) assistance is needed by the patient. It is used by medical professionals and caregivers in the healthcare facility.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MHX	MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

FDA Premarket Submission

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

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
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 57 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 95f5e6a7-9eac-4636-8ad7-f65ae6a45953
Public Version Date: July 08, 2025
Public Version Number: 11
DI Record Publish Date: September 30, 2016