AccessGUDID - DEVICE: Elite Infrared (B484ET1301EXAEA200ZE10)

GUDID

Device Identifier (DI) Information

Brand Name: Elite Infrared
Version or Model: ET13CCEEIIXXXXTAL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Crest Healthcare Supply

Primary DI Number: B484ET1301EXAEA200ZE10
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 151772415 *Terms of Use

Device Description: ET series pillow speakers followed by any alphanumeric characters denoting low energy circuitry difference and cable length. For use with Universal nurse call systems.

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):	No
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?
62165	Nurse call system	An assembly of electronic devices, integrated within a facility infrastructure and/or wireless network, designed to provide an audio/visual signal to summon help when activated in response to a patient’s need for (urgent) assistance. It typically consists of and/or interacts with user- or sensor-activated signal transmitters (e.g., patient-worn pendant, push-buttons, microphones, speakers, fall sensors, smoke alarm, door sensors), a network communicator, and alert communication devices (e.g., server computer, phone, dome lights, audible alarm). The device notifies medical professionals and caregivers and is intended for use in the healthcare facility.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IQA	System, Environmental Control, Powered

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 8 Feet

Device Record Status

Public Device Record Key: eec9aadc-d5c2-4615-924d-ad4da48cf16b
Public Version Date: November 08, 2023
Public Version Number: 1
DI Record Publish Date: October 31, 2023