Q TECH

GUDID 00802526542206

Programmer for the S-ICD® System

CAMERON HEALTH, INC.

Cardiac pulse generator programmer
Primary Device ID00802526542206
NIH Device Record Key89c661c9-d82b-4825-b9dc-50dbc733faaa
Commercial Distribution Discontinuation2015-10-08
Commercial Distribution StatusNot in Commercial Distribution
Brand NameQ TECH
Version Model Number3200
Company DUNS017134557
Company NameCAMERON HEALTH, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100802526542206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWSImplantable cardioverter defibrillator (non-CRT)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-09-11
Device Publish Date2014-09-24

Devices Manufactured by CAMERON HEALTH, INC.

00802526542206 - Q TECH2018-09-11Programmer for the S-ICD® System
00802526542206 - Q TECH2018-09-11 Programmer for the S-ICD® System
00802526521300 - SQ-RX® PULSE GENERATOR2018-07-06 SQ-RX Pulse Generator
00802526524806 - S-ICD® System Patient Screening Tool2018-07-06 Patient Screening Tool
00802526531019 - The Q-GUIDE™ Electrode Insertion Tool2018-07-06 Electrode Insertion Tool
00802526531033 - S-ICD® System Magnet2018-07-06 Magnet
00802526542244 - Q-TECH™2018-07-06 Power Supply for S-ICD Programmer 3200
00802526553707 - HP OFFICEJET 100 Mobile Printer2018-07-06 Printer
00802526562808 - SQ-RX® PULSE GENERATOR2018-07-06 SQ-RX Pulse Generator

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