GEN4 PLUS, RESPONDER 5, ENHANCED 26329

GUDID 00840828181884

GEN4 PLUS, RESPONDER 5, ENHANCED

CURBELL MEDICAL PRODUCTS, INC.

Pillow speaker Pillow speaker Pillow speaker Pillow speaker Pillow speaker Pillow speaker Pillow speaker Pillow speaker Pillow speaker Pillow speaker Pillow speaker Pillow speaker Pillow speaker Pillow speaker
Primary Device ID00840828181884
NIH Device Record Keya8a54a8f-6998-4c6a-9779-d499917343db
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEN4 PLUS, RESPONDER 5, ENHANCED
Version Model Number5C410U-10103005A
Catalog Number26329
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 Numbertrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840828181884 [Primary]
GS100840828181884 [Primary]
GS100840828181884 [Primary]
GS100840828181884 [Primary]
GS100840828181884 [Primary]
GS100840828181884 [Primary]
GS100840828181884 [Primary]
GS100840828181884 [Primary]
GS100840828181884 [Primary]
GS100840828181884 [Primary]
GS100840828181884 [Primary]
GS100840828181884 [Primary]
GS100840828181884 [Primary]
GS100840828181884 [Primary]

FDA Product Code

ILQSystem, Communication, Powered
ILQSystem, Communication, Powered
ILQSystem, Communication, Powered
ILQSystem, Communication, Powered
ILQSystem, Communication, Powered
ILQSystem, Communication, Powered
ILQSystem, Communication, Powered
ILQSystem, Communication, Powered
ILQSystem, Communication, Powered
ILQSystem, Communication, Powered
ILQSystem, Communication, Powered
ILQSystem, Communication, Powered
ILQSystem, Communication, Powered
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 Date2020-10-15
Device Publish Date2020-10-07

On-Brand Devices [GEN4 PLUS, RESPONDER 5, ENHANCED]

00840828171960GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171953GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171946GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171939GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171922GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171915GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171908GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171892GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171885GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171878GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171861GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171854GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171847GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171830GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171823GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171816GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171809GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171793GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171786GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171779GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171762GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171755GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171748GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171731GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171724GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171717GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171700GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171694GEN4 PLUS, RESPONDER 5, ENHANCED
00840828171687GEN4 PLUS, RESPONDER 5, ENHANCED
00840828172257GEN4 PLUS, RESPONDER 5, ENHANCED
00840828172240GEN4 PLUS, RESPONDER 5, ENHANCED
00840828172233GEN4 PLUS, RESPONDER 5, ENHANCED
00840828172226GEN4 PLUS, RESPONDER 5, ENHANCED
00840828172219GEN4 PLUS, RESPONDER 5, ENHANCED
00840828172202GEN4 PLUS, RESPONDER 5, ENHANCED
00840828172196GEN4 PLUS, RESPONDER 5, ENHANCED
00840828172189GEN4 PLUS, RESPONDER 5, ENHANCED
00840828172172GEN4 PLUS, RESPONDER 5, ENHANCED
00840828172165GEN4 PLUS, RESPONDER 5, ENHANCED
00840828172158GEN4 PLUS, RESPONDER 5, ENHANCED
00840828172141GEN4 PLUS, RESPONDER 5, ENHANCED
00840828172134GEN4 PLUS, RESPONDER 5, ENHANCED
00840828172127GEN4 PLUS, RESPONDER 5, ENHANCED
00840828172110GEN4 PLUS, RESPONDER 5, ENHANCED
00840828172103GEN4 PLUS, RESPONDER 5, ENHANCED
00840828172097GEN4 PLUS, RESPONDER 5, ENHANCED
00840828172080GEN4 PLUS, RESPONDER 5, ENHANCED
00840828172073GEN4 PLUS, RESPONDER 5, ENHANCED
00840828172066GEN4 PLUS, RESPONDER 5, ENHANCED
00840828172059GEN4 PLUS, RESPONDER 5, ENHANCED

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