GEN4 PLUS, DIRECT ACCESS 26323

GUDID 00840828181013

GEN4 PLUS, DIRECT ACCESS

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 ID00840828181013
NIH Device Record Key72049f43-3957-499b-914a-4049edd6444d
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEN4 PLUS, DIRECT ACCESS
Version Model Number5C190U-P1030002F
Catalog Number26323
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
GS100840828181013 [Primary]
GS100840828181013 [Primary]
GS100840828181013 [Primary]
GS100840828181013 [Primary]
GS100840828181013 [Primary]
GS100840828181013 [Primary]
GS100840828181013 [Primary]
GS100840828181013 [Primary]
GS100840828181013 [Primary]
GS100840828181013 [Primary]
GS100840828181013 [Primary]
GS100840828181013 [Primary]
GS100840828181013 [Primary]
GS100840828181013 [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 Date2020-09-14
Device Publish Date2020-09-04

On-Brand Devices [GEN4 PLUS, DIRECT ACCESS]

00840828166706GEN4 PLUS, DIRECT ACCESS
00840828166690GEN4 PLUS, DIRECT ACCESS
00840828166683GEN4 PLUS, DIRECT ACCESS
00840828166676GEN4 PLUS, DIRECT ACCESS
00840828166669GEN4 PLUS, DIRECT ACCESS
00840828166652GEN4 PLUS, DIRECT ACCESS
00840828166843GEN4 PLUS, DIRECT ACCESS
00840828166836GEN4 PLUS, DIRECT ACCESS
00840828166829GEN4 PLUS, DIRECT ACCESS
00840828166812GEN4 PLUS, DIRECT ACCESS
00840828166805GEN4 PLUS, DIRECT ACCESS
00840828166799GEN4 PLUS, DIRECT ACCESS
00840828166782GEN4 PLUS, DIRECT ACCESS
00840828166775GEN4 PLUS, DIRECT ACCESS
00840828166768GEN4 PLUS, DIRECT ACCESS
00840828166751GEN4 PLUS, DIRECT ACCESS
00840828166744GEN4 PLUS, DIRECT ACCESS
00840828166737GEN4 PLUS, DIRECT ACCESS
00840828166720GEN4 PLUS, DIRECT ACCESS
00840828169714GEN4 PLUS, DIRECT ACCESS
00840828169707GEN4 PLUS, DIRECT ACCESS
00840828169691GEN4 PLUS, DIRECT ACCESS
00840828169684GEN4 PLUS, DIRECT ACCESS
00840828169677GEN4 PLUS, DIRECT ACCESS
00840828169660GEN4 PLUS, DIRECT ACCESS
00840828169653GEN4 PLUS, DIRECT ACCESS
00840828169646GEN4 PLUS, DIRECT ACCESS
00840828169639GEN4 PLUS, DIRECT ACCESS
00840828169622GEN4 PLUS, DIRECT ACCESS
00840828169615GEN4 PLUS, DIRECT ACCESS
00840828169608GEN4 PLUS, DIRECT ACCESS
00840828169592GEN4 PLUS, DIRECT ACCESS
00840828169585GEN4 PLUS, DIRECT ACCESS
00840828170147GEN4 PLUS, DIRECT ACCESS
00840828170130GEN4 PLUS, DIRECT ACCESS
00840828170123GEN4 PLUS, DIRECT ACCESS
00840828170116GEN4 PLUS, DIRECT ACCESS
00840828170109GEN4 PLUS, DIRECT ACCESS
00840828170093GEN4 PLUS, DIRECT ACCESS
00840828170086GEN4 PLUS, DIRECT ACCESS
00840828170079GEN4 PLUS, DIRECT ACCESS
00840828170062GEN4 PLUS, DIRECT ACCESS
00840828170055GEN4 PLUS, DIRECT ACCESS
00840828170048GEN4 PLUS, DIRECT ACCESS
00840828170031GEN4 PLUS, DIRECT ACCESS
00840828170024GEN4 PLUS, DIRECT ACCESS
00840828170017GEN4 PLUS, DIRECT ACCESS
00840828170000GEN4 PLUS, DIRECT ACCESS
00840828169998GEN4 PLUS, DIRECT ACCESS
00840828169981GEN4 PLUS, DIRECT ACCESS

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