GEN4 INTERACTIVE 22768

GUDID 00840828162180

GEN4 INTERACTIVE

CURBELL MEDICAL PRODUCTS, INC.

Pillow speaker
Primary Device ID00840828162180
NIH Device Record Key1d6bb126-c0a4-4953-b906-d8b9f669d05f
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEN4 INTERACTIVE
Version Model Number4N215E-Y004028
Catalog Number22768
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840828162180 [Primary]

FDA Product Code

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 Date2019-04-30
Device Publish Date2019-04-22

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