OneTouch Ultra

GUDID 20353885013004

LIFESCAN, INC.

Glucose IVD, kit, electrometry
Primary Device ID20353885013004
NIH Device Record Key41d38192-ce21-420b-a854-e58822952023
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneTouch Ultra
Version Model Number024-391
Company DUNS153409313
Company NameLIFESCAN, INC.
Device Count30
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *do not refrigerate
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *do not refrigerate
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *do not refrigerate
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *do not refrigerate
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *do not refrigerate
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *do not refrigerate
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *do not refrigerate
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *do not refrigerate
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *do not refrigerate
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *do not refrigerate
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *do not refrigerate
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *do not refrigerate
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100353885013000 [Primary]
GS120353885013004 [Package]
Contains: 00353885013000
Package: [24 Units]
In Commercial Distribution
GS180353885013006 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-30
Device Publish Date2025-06-20

Devices Manufactured by LIFESCAN, INC.

20353885013004 - OneTouch Ultra2025-06-30
20353885013004 - OneTouch Ultra2025-06-30
20353885012656 - OneTouch Ultra Blue Test Strips2022-08-05 OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch U

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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