ZEPHYR,800,10,SIP=TV,PUFF=N,JERON 680 30558

GUDID 00840828195980

ZEPHYR,800,10,SIP=TV,PUFF=N,JERON 680

CURBELL MEDICAL PRODUCTS, INC.

Fixed call button
Primary Device ID00840828195980
NIH Device Record Keyf672b984-8399-4e3d-8e64-4d3207f8a81b
Commercial Distribution StatusIn Commercial Distribution
Brand NameZEPHYR,800,10,SIP=TV,PUFF=N,JERON 680
Version Model NumberGEB-19C0-405A-N
Catalog Number30558
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
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840828195980 [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 Date2026-02-19
Device Publish Date2026-02-11

Devices Manufactured by CURBELL MEDICAL PRODUCTS, INC.

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00840828196109 - GEN4 PLUS, DIRECT ACCESS2026-03-19 GEN4 PLUS, DIRECT ACCESS
00840828196116 - GEN4 INTERACTIVE2026-03-19 GEN4 INTERACTIVE
00840828196123 - RESPONDER 5, INTERACTIVE2026-03-19 RESPONDER 5, INTERACTIVE
00840828196130 - RESPONDER 5, INTERACTIVE2026-03-19 RESPONDER 5, INTERACTIVE
00840828196147 - RESPONDER 5, INTERACTIVE2026-03-19 RESPONDER 5, INTERACTIVE
00840828196154 - RESPONDER 5, INTERACTIVE2026-03-19 RESPONDER 5, INTERACTIVE

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