GEN4 DIGITAL 22331

GUDID 00840828160506

GEN4 DIGITAL

CURBELL MEDICAL PRODUCTS, INC.

Pillow speaker
Primary Device ID00840828160506
NIH Device Record Keyf112b672-ef73-4d57-8e9d-04abdc384e07
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEN4 DIGITAL
Version Model Number4D190U-020002F
Catalog Number22331
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
GS100840828160506 [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 Date2018-02-23

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