S-ICD® System Patient Screening Tool

GUDID 00802526524806

Patient Screening Tool

CAMERON HEALTH, INC.

Cardiac pulse generator programmer
Primary Device ID00802526524806
NIH Device Record Key8d7f6e53-9265-4108-8aa8-28ff86fb9b64
Commercial Distribution StatusIn Commercial Distribution
Brand NameS-ICD® System Patient Screening Tool
Version Model Number4744
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100802526524806 [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 Number3
Public Version Date2018-07-06
Device Publish Date2014-09-24

Devices Manufactured by CAMERON HEALTH, INC.

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 Tool2018-07-06Patient Screening Tool
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

Trademark Results [S-ICD]

Mark Image

Registration | Serial
Company
Trademark
Application Date
S-ICD
S-ICD
76376420 3064037 Dead/Cancelled
Cameron Health, Inc.
2002-02-25

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