GEN4 DIGITAL 26339

GUDID 00840828181754

GEN4 DIGITAL

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 ID00840828181754
NIH Device Record Key207a7ec9-0276-477c-9ec8-0c6a2d9021a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEN4 DIGITAL
Version Model Number4D290U-Z10402C
Catalog Number26339
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

Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840828181754 [Primary]
GS100840828181754 [Primary]
GS100840828181754 [Primary]
GS100840828181754 [Primary]
GS100840828181754 [Primary]
GS100840828181754 [Primary]
GS100840828181754 [Primary]
GS100840828181754 [Primary]
GS100840828181754 [Primary]
GS100840828181754 [Primary]
GS100840828181754 [Primary]
GS100840828181754 [Primary]
GS100840828181754 [Primary]
GS100840828181754 [Primary]

FDA Product Code

IQASystem, Environmental Control, Powered
IQASystem, Environmental Control, Powered
IQASystem, Environmental Control, Powered
IQASystem, Environmental Control, Powered
IQASystem, Environmental Control, Powered
IQASystem, Environmental Control, Powered
IQASystem, Environmental Control, Powered
IQASystem, Environmental Control, Powered
IQASystem, Environmental Control, Powered
IQASystem, Environmental Control, Powered
IQASystem, Environmental Control, Powered
IQASystem, Environmental Control, Powered
IQASystem, Environmental Control, Powered
IQASystem, Environmental Control, 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 DIGITAL]

00840828171458GEN4 DIGITAL
00840828173520GEN4 DIGITAL
00840828173469GEN4 DIGITAL
00840828173605GEN4 DIGITAL
00840828174343GEN4 DIGITAL
00840828174886GEN4 DIGITAL
00840828177658GEN4 DIGITAL
00840828177641GEN4 DIGITAL
00840828177627GEN4 DIGITAL
00840828177436GEN4 DIGITAL
00840828173919GEN4 DIGITAL
00840828173902GEN4 DIGITAL
00840828173315GEN4 DIGITAL
00840828172912GEN4 DIGITAL
00840828172851GEN4 DIGITAL
00840828165044GEN4 DIGITAL
00840828164924GEN4 DIGITAL
00840828164566GEN4 DIGITAL
00840828163231GEN4 DIGITAL
00840828162135GEN4 DIGITAL
00840828162081GEN4 DIGITAL
00840828161862GEN4 DIGITAL
00840828161817GEN4 DIGITAL
00840828161664GEN4 DIGITAL
00840828161299GEN4 DIGITAL
00840828161190GEN4 DIGITAL
00840828161039GEN4 DIGITAL
00840828160988GEN4 DIGITAL
00840828160650GEN4 DIGITAL
00840828160643GEN4 DIGITAL
00840828160506GEN4 DIGITAL
00840828160438GEN4 DIGITAL
00840828160346GEN4 DIGITAL
00840828160285GEN4 DIGITAL
00840828160278GEN4 DIGITAL
00840828160247GEN4 DIGITAL
00840828160230GEN4 DIGITAL
00840828160223GEN4 DIGITAL
00840828160209GEN4 DIGITAL
00840828160186GEN4 DIGITAL
00840828159746GEN4 DIGITAL
00840828159722GEN4 DIGITAL
00840828159630GEN4 DIGITAL
00840828159616GEN4 DIGITAL
00840828159586GEN4 DIGITAL
00840828159432GEN4 DIGITAL
00840828159326GEN4 DIGITAL
00840828159050GEN4 DIGITAL
00840828159043GEN4 DIGITAL
00840828159036GEN4 DIGITAL

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.