GEN4 INTERACTIVE 25519

GUDID 00840828174398

GEN4 INTERACTIVE

CURBELL MEDICAL PRODUCTS, INC.

Pillow speaker
Primary Device ID00840828174398
NIH Device Record Key48f126d9-1176-4b61-a1af-5ab13a0375ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEN4 INTERACTIVE
Version Model Number45370E-S103468
Catalog Number25519
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
GS100840828174398 [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 Date2019-10-09
Device Publish Date2019-10-01

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