GEN4 DIRECT ACCESS 20674

GUDID 00840828147491

GEN4 DIRECT ACCESS

CURBELL MEDICAL PRODUCTS, INC.

Pillow speaker
Primary Device ID00840828147491
NIH Device Record Key201f1f44-b970-4f0f-be4f-6e4bdbbc35b9
Commercial Distribution Discontinuation2019-06-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGEN4 DIRECT ACCESS
Version Model Number4C370N-Z119AEA
Catalog Number20674
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
GS100840828147491 [Primary]

FDA Product Code

ILQSystem, Communication, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-06-24
Device Publish Date2016-09-24

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