REGO 1.1,PID,WT,PN,TL,FD,14' 27855

GUDID 00840828194242

CURBELL MEDICAL PRODUCTS, INC.

Pillow speaker
Primary Device ID00840828194242
NIH Device Record Key6572207a-eae0-495e-9ecd-fc2bd6439530
Commercial Distribution StatusIn Commercial Distribution
Brand NameREGO 1.1,PID,WT,PN,TL,FD,14'
Version Model NumberPD11-100400000E
Catalog Number27855
Company DUNS796452311
Company NameCURBELL MEDICAL PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18002357500
Emailmwinter@curbell.com
Phone18002357500
Emailmwinter@curbell.com
Phone18002357500
Emailmwinter@curbell.com
Phone18002357500
Emailmwinter@curbell.com
Phone18002357500
Emailmwinter@curbell.com
Phone18002357500
Emailmwinter@curbell.com
Phone18002357500
Emailmwinter@curbell.com
Phone18002357500
Emailmwinter@curbell.com
Phone18002357500
Emailmwinter@curbell.com
Phone18002357500
Emailmwinter@curbell.com
Phone18002357500
Emailmwinter@curbell.com
Phone18002357500
Emailmwinter@curbell.com
Phone18002357500
Emailmwinter@curbell.com
Phone18002357500
Emailmwinter@curbell.com
Phone18002357500
Emailmwinter@curbell.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840828194242 [Primary]

FDA Product Code

ILQSystem, Communication, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-07
Device Publish Date2025-02-27