Elite Digital
| Catalog Number: | N/A |
|---|---|
| Company Name: | Crest Healthcare Supply |
| Device Combination Product: | N/A |
| Device Commercial Dsitribution End Date: | 2019-03-21 |
| Device Commercial Dsitribution Status: | Not in Commercial Distribution |
| Device Count: | 1 |
| Device Description: | XN series pillow speakers followed by any alphanumeric characters denoting low energy circuitry difference and cable length. For use with Ektacom nurse call system. |
| Device hctp: | N/A |
| Device kit: | N/A |
| Device Publish Date: | 2017-01-24 |
| Device Record Status: | Published |
| Direct Market Exempt: | true |
| Has Donation ID number? | N/A |
| DUNS Number: | 151772415 |
| Has Expiration Date? | N/A |
| Is Labelled as NRL: | N/A |
| Is Labelled As No NRL: | N/A |
| Has Lot Batch Number: | N/A |
| Has Manufacutring Date: | true |
| MRI Safety Status: | Labeling does not contain MRI Safety Information |
| Is OTC? | N/A |
| Is Devic Premarket Exempt: | true |
| Public Device Record Key: | 69c6218d-0545-47ae-8755-45625cf06209 |
| Public Version Date: | 2019-03-22 |
| Public Version Number: | 3 |
| Public Version Status: | Update |
| Is Rx? | N/A |
| Has Serial Number? | N/A |
| Is Single Use: | N/A |
| Version Model Number: | XN15CCEIXXXXTAAYL |
| Adress: | Phone:1-320-275-3382 Extension: Email: customerservice@cresthealthcare.com |
Storage Condition
Storage Handling Type
Storage Handling High
Storage Handling Low
Storage Handling Special Condition
N/A
N/A
N/A
N/A
GMDN Terms
GMDN Name
GMDN Term Definition
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.
Identifiers
Device ID
Device ID Type
Issuing Agency
Contains DI No
Pkg Qty
Pkg Discontinue dt
Pkg Status
Pkg Type
XN15CCEIXXXXTAAYL0
Primary
HIBCC
Sterilization
Is Device Sterile
Is Steriliztion Prior Use
Sterilization Method
false
false
Product Codes
Product Code
Product Code Name
IQA
System, Environmental Control, Powered
Pre Market Submisison
Submission Number
Supplement Number
N/A
N/A