GEN4 DIGITAL 22263

GUDID 00840828160247

GEN4 DIGITAL

CURBELL MEDICAL PRODUCTS, INC.

Pillow speaker
Primary Device ID00840828160247
NIH Device Record Key9c23f38c-3bf4-4662-badb-c4f02050ac1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEN4 DIGITAL
Version Model Number4D330U-0200028
Catalog Number22263
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840828160247 [Primary]

FDA Product Code

IQASystem, Environmental Control, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2018-01-29

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00840828160247GEN4 DIGITAL
00840828160230GEN4 DIGITAL
00840828160223GEN4 DIGITAL
00840828160209GEN4 DIGITAL
00840828160186GEN4 DIGITAL
00840828159746GEN4 DIGITAL
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00840828159630GEN4 DIGITAL
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00840828159586GEN4 DIGITAL
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