Oxitone

GUDID 07290017350004

Pulse Oximetry

OXITONE MEDICAL LTD

Wearable multiple physiological parameter recorder, reusable
Primary Device ID07290017350004
NIH Device Record Key8955b5e0-4554-4054-a3bf-6e283eb30bc6
Commercial Distribution StatusIn Commercial Distribution
Brand NameOxitone
Version Model Number1000M
Company DUNS533834359
Company NameOXITONE MEDICAL LTD
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+972542699876
Emailofer.harpak@oxitone.com
Phone+972542699876
Emailofer.harpak@oxitone.com
Phone+972542699876
Emailofer.harpak@oxitone.com
Phone+972542699876
Emailofer.harpak@oxitone.com
Phone+972542699876
Emailofer.harpak@oxitone.com
Phone+972542699876
Emailofer.harpak@oxitone.com
Phone+972542699876
Emailofer.harpak@oxitone.com
Phone+972542699876
Emailofer.harpak@oxitone.com
Phone+972542699876
Emailofer.harpak@oxitone.com
Phone+972542699876
Emailofer.harpak@oxitone.com
Phone+972542699876
Emailofer.harpak@oxitone.com
Phone+972542699876
Emailofer.harpak@oxitone.com
Phone+972542699876
Emailofer.harpak@oxitone.com
Phone+972542699876
Emailofer.harpak@oxitone.com
Phone+972542699876
Emailofer.harpak@oxitone.com
Phone+972542699876
Emailofer.harpak@oxitone.com
Phone+972542699876
Emailofer.harpak@oxitone.com
Phone+972542699876
Emailofer.harpak@oxitone.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290017350004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-12
Device Publish Date2023-07-04

Trademark Results [Oxitone]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OXITONE
OXITONE
86499516 5612128 Live/Registered
Oxitone Medical Ltd.
2015-01-09
OXITONE
OXITONE
72426292 0960210 Dead/Expired
OLIN CORPORATION
1972-06-05

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