OneTouch Ultra 010-458

GUDID 20353885458027

One Touch Ultra Control Solution

LifeScan Europe GmbH

Glucose monitoring system IVD, point-of-care
Primary Device ID20353885458027
NIH Device Record Keyb47b12ae-dee3-4ef9-9815-71aadd1f496f
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneTouch Ultra
Version Model Number010-458
Catalog Number010-458
Company DUNS480240820
Company NameLifeScan Europe GmbH
Device Count150
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1 8002278862
EmailXX@XX.XX
Phone+1 8002278862
EmailXX@XX.XX
Phone+1 8002278862
EmailXX@XX.XX
Phone+1 8002278862
EmailXX@XX.XX
Phone+1 8002278862
EmailXX@XX.XX
Phone+1 8002278862
EmailXX@XX.XX
Phone+1 8002278862
EmailXX@XX.XX
Phone+1 8002278862
EmailXX@XX.XX
Phone+1 8002278862
EmailXX@XX.XX
Phone+1 8002278862
EmailXX@XX.XX
Phone+1 8002278862
EmailXX@XX.XX
Phone+1 8002278862
EmailXX@XX.XX
Phone+1 8002278862
EmailXX@XX.XX
Phone+1 8002278862
EmailXX@XX.XX

Device Identifiers

Device Issuing AgencyDevice ID
GS100353885458023 [Primary]
GS120353885458027 [Package]
Contains: 00353885458023
Package: Shipper case [48 Units]
In Commercial Distribution
NDC/NHRIC53885-458-02 [Secondary]
GS180353885458029 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-10
Device Publish Date2020-07-31

On-Brand Devices [OneTouch Ultra]

20353885006235One Touch Ultra Control Solution
20353885458027One Touch Ultra Control Solution

Trademark Results [OneTouch Ultra]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ONETOUCH ULTRA
ONETOUCH ULTRA
77223516 3491332 Live/Registered
Johnson & Johnson
2007-07-06
ONETOUCH ULTRA
ONETOUCH ULTRA
76661414 3436618 Dead/Cancelled
JOHNSON & JOHNSON
2006-06-12
ONETOUCH ULTRA
ONETOUCH ULTRA
76661413 3462824 Dead/Cancelled
JOHNSON & JOHNSON
2006-06-12

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