GEN4 DIRECT ACCESS 25652

GUDID 00840828174909

GEN4 DIRECT ACCESS

CURBELL MEDICAL PRODUCTS, INC.

Pillow speaker
Primary Device ID00840828174909
NIH Device Record Keyd306e685-494e-4c29-b6a1-2d43c2ee391a
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEN4 DIRECT ACCESS
Version Model Number4C330U-P100001
Catalog Number25652
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

Phone18002357500
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS100840828174909 [Primary]

FDA Product Code

ILQSystem, Communication, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-27
Device Publish Date2019-11-19

On-Brand Devices [GEN4 DIRECT ACCESS]

00840828166713GEN4 DIRECT ACCESS
00840828172844GEN4 DIRECT ACCESS
00840828172875GEN4 DIRECT ACCESS
00840828172905GEN4 DIRECT ACCESS
00840828172967GEN4 DIRECT ACCESS
00840828172936GEN4 DIRECT ACCESS
00840828160155GEN4 DIRECT ACCESS
00840828172981GEN4 DIRECT ACCESS
00840828173391GEN4 DIRECT ACCESS
00840828173513GEN4 DIRECT ACCESS
00840828173483GEN4 DIRECT ACCESS
00840828147491GEN4 DIRECT ACCESS
00840828173599GEN4 DIRECT ACCESS
00840828173582GEN4 DIRECT ACCESS
00840828173575GEN4 DIRECT ACCESS
00840828174466GEN4 DIRECT ACCESS
00840828175234GEN4 DIRECT ACCESS
00840828174909GEN4 DIRECT ACCESS

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